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U.S. Department of Health and Human Services

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Enforcement Report for May 30, 2012

 

"As part of FDA's efforts to increase the transparency of its compliance and enforcement data, FDA will soon be introducing a very different Enforcement Report format aiming to deliver a simpler, clearer report that encourages data download and analyses while also providing savings and encouraging future innovation for Government. Instead of the narrative report you see now, you will find a data-driven report encouraging innovative stakeholders to extract more intelligence out of the data and providing FDA a baseline as it moves forward in its efforts to integrate the Agency's compliance and enforcement data. 
 
We expect to publish the new report mid-June. This will not be the first and only iteration of the report. We want your feedback - the good, the bad, and the ugly. So please be on the lookout for the new report and e-mail us at webmail@oc.fda.gov with your comments."
 
May 30, 2012                                                                                              12-22
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
SEMITA DE PINA (Sweet Pineapple Cake), Net Wt. 8 oz., UPC 8 94737 00196 2 --- The product is packaged in a clear plastic package. Recall # F-1259-2012
CODE
SELL BY 011112
RECALLING FIRM/MANUFACTURER
Maxipan Bakery Corp., West Hempstead, NY, by press release on November 23, 2011 and by visits between November 23, 2011 and December 16, 2011. New York initiated recall is complete.
REASON
The product contained undeclared milk allergens (287 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY, NJ
____________________________
PRODUCT
Cupcake 6 pk - Bakery New Wt. - 0 oz (255g) Variety packs may contain various Flavors of cupcake including chocolate, red velvet, vanilla and carrot cake. UPC 1 16521 70699 8. Recall # F-1260-2012
CODE
All Best by dates prior to May 10, 2012.
RECALLING FIRM/MANUFACTURER
Whole Foods Market, Emeryville, CA, by press release on May 11, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Whole Foods Market received a complaint that a piece of walnut was found in a carrot cake cupcake which was part of a variety six pack. Walnuts were not listed in the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
CA
___________________________________
PRODUCT
Caf�-Tasse Noir Bar (Dark Chocolate), 45gr (1.58 oz) Item Code: L11303249. Product of Belgium. Recall # F-1261-2012
CODE
Date Code: 15 SEPT 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Belgium's Chocolate Source Inc., Wellesley, MA, by telephone and email on April 25, 2012 and by press release on April 26, 2012.
Manufacturer: Cafe Tasse S.A. Societe Anonyme, Wauthier-Braine, Belgium. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
23 cases (30 bars.case)
DISTRIBUTION
CA, MA, VA, WA
___________________________________
PRODUCT
Fiji's Lemon Bar Bliss, gift no. 4377, Net Wt. 1 lb. (453.6g). Recall # F-1262-2012
CODE
Gift No. 4377
RECALLING FIRM/MANUFACTURER
Recalling Firm: Figi's, Inc., Marshfield, WI, by telephone on May 2, 2012 and by press release on May 3, 2012.
Manufacturer: Figi's Inc., Neillsville, WI. Firm initiated recall is ongoing.
REASON
Product contains almonds which are not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
51 units
DISTRIBUTION
CA, FL, IA, IL, IN, LA, MI, MN, MO, NY, OR, PA, TX, UT, VA, WI
___________________________________
PRODUCT
1) Cold Smoked Sprats, packed in bulk cases. There is no labeling available. Recall # F-1263-2012;
 
2)Schmaltz Herring, packed in white plastic buckets with salt brine. There is no labeling available. Recall # F-1264-2012
CODE
1) Lot # 54;
2) Lot # 51
RECALLING FIRM/MANUFACTURER
D & M Smoked Fish, Inc., Jamaica, NY, by press release on March 14, 2012. New York initiated recall is complete.
REASON                                                                                                                                                 
The products were found to be not properly eviscerated prior to processing based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
1) Approximately 54 lbs.; 2) 7 buckets (approximately 30 fish per bucket)
DISTRIBUTION
NYC
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
Faragello Food Industries Strawberry Jelly. Made in Egypt. Recall # F-1265-2012
CODE
PROD 2011/07 - Best before 2013/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Avalon Coffee & Tea Inc., N Brunswick, NJ, by telephone January 9-13, 2012.
Manufacturer: The Egyptian Food Co., New Borg El-arab, Egypt. New York initiated recall is ongoing.
REASON                                                                                                                                                 
Strawberry Jelly labeled to contain an unapproved color (E122) as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
150 cases (6 plastic sleeves containing 12 retail packages per case)
DISTRIBUTION
NJ, NY
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions toCDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
______________________________________
PRODUCT
 
None
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
Kold Sore Spray with liquid sea mineral, 1 fl oz bottle. Recall # D-1355-2012
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Wholistic Herbs, Inc., Dallas, TX, by press release on February 9, 2012 and by letters on February 9, 2012 and March 8, 2012. Firm Initiated recall is ongoing.
REASON
Non-Sterility: This product is intended for use in the eye and was manufactured under non sterile conditions.
VOLUME OF PRODUCT IN COMMERCE
313 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Koff & Kold Spray (huang liam, lugol iodine, quercetin), 1 fl oz bottles. Recall # D-1356-2012
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Wholistic Herbs, Inc., Dallas, TX, by press release on February 9, 2012 and by letters on February 9, 2012 and March 8, 2012. Firm Initiated recall is ongoing.
REASON
CGMP Deviations: This product was manufactured in a manner that lacks good manufacturing practices.
VOLUME OF PRODUCT IN COMMERCE
973 bottles
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1158-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1160-12
CODE
1) Unit: 9037532;
2) Units: 9036757; 9035321
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated May 18, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Ohio, Switzerland
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1371-12;
 
2)Platelets Pheresis Leukocytes Reduced. Recall # B-1372-12
CODE
1) Units: 7585090; 7585090; 7526216; W091009217621; W091009148644; 7862645; W091009174067; W091009210949; W091009210949; W091010241908; W091009214446; W091009293319; W091010241908; W091010241237; W091009214446; W091009124135; W091009317016;
 
2) Units: W091009217621; W091009144033; W091009144033; 7569935; W091010236520; W09101000665; W09109317061; W091009293319; W091009210949; W091009148644; W091009114295; W091009114295; 7526865; 7519928; W091009286399; W091009286399; W091009271320; W091009214960; W091010208522; W091009317673; W091009317673; W091009174067; W091009174067; W091009190538; W091010157868; W091009271832; W091009139287; W091010141362; W091010122849; W091010111974; W091010236475; W091010236475; W091010208215; 7613083; W091009329862;7 644675; W091009124135; W091009329862; W091009271320; W091010180081; 7896427; W091010246506; W091010246506; W091010221646; W091010201903; W091010201553; W091010201553; W091010157868; W091010141362; W091010111974; W091009283707; W091009283707; W091009244022; W091009175991; W091009175991; W091009175172; W091009131678; 7610552; 7610552; 7569935; W091010148496; W091010148496; W091010148496; W091009139569; 7896427;7628034; 7628034; W091010236204; W091010236204; W091009189599; W091010180081; 7526865; W091010175494; W091010208215; W091009139287; W091010201903; W091010196833; W091010196833; W091010196833; W091010185089; W091010185089; W091010185089; W091010175494; W091010142924; W091009318054; W091009318054; W091009303122; W091009269312; W091009244022; W091009214446; W091009214960; W091009185388; W091009162463; W091009162463; W091009131678; W091009129702; 7852574; 7638470; 7625079; 7625079; 7575686; 7585090; 7569935; W091010236520; W091010236520; W091010208902; W091010208902; W091010208902; W091010208215; W091010180081; W091010148068; W091010148068; W091009210949; W091009190538; W091009139287; W091009139569; 7862645; 7862645; 7862216; 7862216; 7628439; 7613083; 7526216; W091010122849; W091010221646; W091010175494; W091010142924; W091009329862; W091009271832; W091009193425; W091009185388; W091009162463; W091009129702; W091009117766; 7575686; W091010241908; W091010236475; W091010148068; W091009317673; W091009189599; W091009124135; 7896427; 7644675; 7862216; W091009114295; W091010241237; W091010200665; W091009190538; W091010221646; W091009303122; W091009269312; W091009175172; W091009129702; W091009117766; W091010208522; W091010200665; W091009189599; W091009148644; 7628439; 7628439; 7613083; 7526865; 7519928; 7519928; W091009193425
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by facsimile and telephone on May 16, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
181 units
DISTRIBUTION
MO, OK, MS, TX, NJ, MI, TN, NY, SC, and AR
___________________________________
PRODUCT
Cw High Res SSP UniTray� Kit, AllSet+" Gold SSP HLA-Cw Locus High Res Kit - 10 Tests, Catalog # 4719010, 4719110, 540300. ALLSET GOLD CW HIGH RES SSP ( Model #54030D); CW HIGH RES SSP UNITRAY 10TEST (Model #4719010) and CWHIGH RES SSP UNITRAY W/TAQ10 (Model 4719110). Recall # B-1373-12
CODE
None
RECALLING FIRM/MANUFACTURER
Life Technologies, Inc., Brown Deer, WI, by letters dated January 12, 2012 and February 6, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Life Technologies PCR-based HLA typing methods, associated with false positive results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5,614 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1375-12;
2) Platelets Pooled. Recall # B-1376-12
CODE
1) Unit: W141607577285;
2) Pool # W141607900114 (contains unit W141607577285)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by facsimile on November 5, 2007.
Manufacturer: Puget Sound Blood Center, Silverdale, WA. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1377-12;
2) Plasma Frozen Within 24 hours (FP24). Recall # B-1378-12
CODE
1) Units: 42FW44837, 42FW44841, 42FW44835, 42FW44844;
2) Unit: 42FW44835
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Cleveland, OH, by telephone on October 29, 2007 and by letter dated November 7, 2007. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, which did not meet the minimum specification for volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
OH, NB
___________________________________
PRODUCT
Source Plasma. Recall # B-1379-12
CODE
Units: 0421494605, 0421492576, 0421492004, 0421490163, 0421489537, 0421467774, 0421467219, 0421465350, 0421464803, 0421462891, 0421462141, 0421460435, 0421459551, 0421458158, 0421457199, 0421455350, 0421454624, 0421452427, 0421450729, 0421449470, 0421448107, 0421447093, 0421439732, 0421437770, 0421437257, 0421434607, 0421433604, 0421431373, 0421430303
RECALLING FIRM/MANUFACTURER
Csl Plasma, Inc., Lansing, MI, by e-mail on May 19, 2011. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Source Plasma. Recall # B-1380-12
CODE
Units: 0530454156, 0530446514, 0530445795, 0530445171, 0530444500, 0530443415, 0530442860, 0530442157, 0530441368, 0530440931, 0530439857, 0530439087, 0530438658, 0530437961, 0530437721, 0530436857, 0530436491, 0530436095, 0530435450, 0530433405, 0530433155
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lexington, KY, by electronic notification on March 21, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
IL, Germany
___________________________________
PRODUCT
Source Plasma. Recall # B-1381-12
CODE
Units: 0530472729, 0530471974, 0530471283, 0530463453, 0530463131, 0530461015, 0530460594, 0530460091, 0530456013, 0530447279, 0530445948, 0530445682, 0530442561, 0530442273, 0530441775, 0530441010, 0530440737, 0530440242, 0530440029
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lexington, KY, by electronic notification on June 7, 2007. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
IN, IL, Germany
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1383-12
CODE
Unit: W141607453770
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by e-mail on January 30, 2008. 
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-1390-12
CODE
Units: 5280098194, 5280097375, 5280096563, 5280092905, 5280091791, 5280090290, 5280089724, 5280089140, 5280088610, 5280087583, 5280084557, 5280084123, 5280083107, 5280082438, 5280082149, 5280081315, 5280080634, 5280079009, 5280078288, 5280076067, 5280075446, 5280075123, 5280074466, 5280073957, 5280072045, 5280067544, 5280066767
RECALLING FIRM/MANUFACTURER
Recalling Firm: Octapharma Plasma, Inc., Charlotte, NC, by email on July 1, 2011 and by fax on July 11, 2011. 
Manufacturer: Octapharma Plasma, Inc., Lubbock, TX. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1391-12
CODE
Unit: 8222705
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on July 18, 2005 and follow-up letter on August 8, 2005.
Manufacturer: Downtown Center, San Francisco, CA. Firm initiated recall is complete
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1393-12
CODE
Unit: LG70175
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, via telephone on July 29, 2005. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood product, which was collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1394-12
CODE
Unit: 084T25227
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by telephone on August 23, 2005 and by letter on September 28, 2005.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1396-12;
2) Plasma Frozen. Recall # B-1397-12
CODE
1) and 2) Units: 084T32983
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, via letter dated August 25, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1398-12
CODE
Units: 0460608435; 0460607551; 0460606606; 0460606405; 0460605364; 0460604961; 0460603889; 0460603104; 0460602467; 0460599532; 0460598452; 0460596092; 0460595615; 0460594366; 0460594020; 0460592424; 0460591448; 0460589920; 0460587809; 0460587029; 0460586375; 0460585528; 0460582161; 0460581603; 0460579175; 0460578794; 0460577266; 0460576006; 0460574900; 0460573760; 0460572903; 0460569369; 0460568928; 0460564709; 0460561407; 0460553212
RECALLING FIRM/MANUFACTURER
Recalling Firm: CSL Plasma, Inc., Boca Raton, FL, via e-mail on January 20, 2010. 
Manufacturer: CSL Plasma, Dallas, TX. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood products collected from a donor whose physical examination documentation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
IN
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-1399-12;
2)Red Blood Cells Leukocytes Reduced. Recall #B-1400-12
CODE
1) and 2) Units: 6048046, 6028425, 6027856
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone and fax on February 27, 2007.
Manufacturer:North Bay Center, Fairfield, CA. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA and Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1401-12
CODE
Unit: 23197911
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on February 4, 2008 and follow-up letter dated February 22, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported living in a malarial endemic area within the past three years, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1406-12
CODE
Unit: 6050327
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on January 3, 2006. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1408-12
CODE
Unit: 2906564
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone on January 12, 2006 and letter on January 17, 2006. 
Manufacturer: Marin Center, San Rafael, CA. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Plasma Cryoprecipitated Reduced. Recall #B-1420-12;
2) Red Blood Cells. Recall # B-1421-12;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1422-12;
4) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1423-12;
5) Platelets Pheresis Leukocytes Reduced. Recall # B-1424-12;
6) Recovered Plasma. Recall # B-1425-12
CODE
1) Units: 2101273, 9174812, 9315326;
 
2) Units: 2115117, 2115139, 2115169, 2115179, 2115183, 2115185, 2115189, 2115192, 2115195, 2115196, 6810709, 6812649, 6812654, 6812657, 6812658, 6937462, 9617627;
 
3) Units: 2101270, 2101271, 2101272, 2101274, 2101275, 2101277, 2101278, 2101279, 2101280, 2101283, 2101284, 2101285, 2101286, 2101287, 2101288, 2101289, 2101290, 2101291, 2101293, 2101294, 2101295, 2101297, 2101298, 2101301, 2101302, 2101303, 2101304, 2101305, 2101306, 2101307, 2107132, 2107133, 2107134, 2107135, 2107136, 2107139, 2107140, 2107141, 2107142, 2107143, 2107144, 2107146, 2107147, 2107148, 2107149, 2107150, 2107151, 2107154, 2107155, 2107156, 2107157, 2107158, 2107159, 2107160, 2107161, 2107162, 2115111, 2115112, 2115114, 2115115, 2115116, 2115118, 2115119, 2115120, 2115121, 2115122, 2115123, 2115124, 2115126, 2115128, 2115129, 2115130, 2115132, 2115133, 2115134, 2115135, 2115136, 2115137, 2115138, 2115140, 2115141, 2115142, 2115143, 2115144, 2115145, 2115146, 2115147, 2115148, 2115149, 2115150, 2115151, 2115152, 2115153, 2115154, 2115155, 2115156, 2115157, 2115158, 2115160, 2115161, 2115162, 2115164, 2115165, 2115166, 2115167, 2115168, 2115170, 2115171, 2115173, 2115174, 2115175, 2115176, 2115178, 2115180, 2115181, 2115186, 2115187, 2115188, 2115190, 2115191, 2115193, 2115194, 6809295, 6809296, 6809297, 6809298, 6809299, 6809300, 6809301, 6809302, 6809303, 6809304, 6809305, 6809308, 6809309, 6809310, 6809311, 6809312, 6809314, 6809315, 6809316, 6809317, 6809318, 6809321, 6809322, 6809323, 6809324, 6809325, 6809326, 6809327, 6809328, 6809329, 6810701, 6810702, 6810703, 6810704, 6810705, 6810706, 6810707, 6810708, 6810711, 6810712, 6810713, 6810714, 6810715, 6810718, 6810719, 6810720, 6812642, 6812643, 6812644, 6812645, 6812650, 6812651, 6812652, 6812653, 6812656, 6812659, 6937448, 6937449, 6937450, 6937451, 6937452, 6937453, 6937454, 6937455, 6937457, 6937458, 6937459, 6937460, 6937463, 6937464, 6937467, 6937468, 6937469, 6937470, 6937471, 6937473, 6937474, 6937475, 6937476, 6937477, 6937479, 6937480, 6937481, 6937482, 6937483, 6937485, 6937487, 6937488, 9129389, 9129391, 9129392, 9129393, 9129395, 9129396, 9129397, 9130789, 9130791, 9130792, 9130793, 9130794, 9130795, 9130796, 9130797, 9174796, 9174799, 9174800, 9174801, 9174802, 9174803, 9174804, 9174805, 9174806, 9174807, 9174808, 9174809, 9174811, 9174812, 9174813, 9174816, 9174817, 9174818, 9174819, 9174820, 9174821, 9174822, 9174823, 9174825, 9174830, 9174832, 9174835, 9174836, 9174838, 9174841, 9174842, 9174843, 9174845, 9213107, 9213108, 9213109, 9213110, 9213111, 9213112, 9213113, 9213114, 9213115, 9213116, 9213117, 9213118, 9213119, 9213121, 9213122, 9213123, 9213124, 9213125, 9213126, 9213127, 9213128, 9213129, 9213131, 9213132, 9213133, 9213134, 9213135, 9213136, 9213138, 9213139, 9213140, 9213141, 9213143, 9213144, 9213145, 9213146, 9213147, 9213148, 9315321, 9315322, 9315323, 9315324, 9315330, 9315331, 9315332, 9315335, 9315336, 9315337, 9315338, 9315340, 9315341, 9315343, 9315346, 9315347, 9315348, 9315349, 9315350, 9315352, 9315353, 9315354, 9315356, 9315357, 9315359, 9315360, 9315361, 9315363, 9315364, 9315365, 9315366, 9315367, 9315368, 9315369, 9315371, 9315372, 9315373, 9315374, 9315375, 9315377, 9315378, 9315380, 9315382, 9315383, 9315384, 9315385, 9315386, 9315388, 9315389, 9315390, 9315391, 9315393, 9315394, 9315395, 9414992, 9414994, 9414995, 9414996, 9414997, 9414998, 9414999, 9415000, 9415001, 9415003, 9415004, 9415005, 9415006, 9415009, 9415010, 9415011, 9415012, 9415013, 9415014, 9415015, 9415016, 9415017, 9415018, 9415019, 9415020, 9415021, 9415023, 9415024, 9415026, 9415027, 9415028, 9415029, 9415030, 9415031, 9415032, 9415033, 9415034, 9415035, 9415036, 9415037, 9415038, 9617604, 9617606, 9617609, 9617612, 9617613, 9617614, 9617616, 9617619, 9617620, 9617622, 9617624, 9617625, 9617626, 9617628, 9617630, 9617633, 9617635, 9617637, 9617638, 9617639, 9617640, 9617641, 9617644, 9617646;
 
4) Units: 2101296 Part 1, 9315358 Part 1, 9315358 Part 2, 9415007 Part 3, 9415025 Part 1, 9415025 Part 3;
 
5) Units: 2101269 Part 1, 2101276 Part 1, 2101296 Part 2, 2101300 Part 1, 9174797 Part 1, 9174815 Part 1, 9174815 Part 2, 9174824 Part 1, 9174824 Part 2, 9174826 Part 1, 9174826 Part 2, 9174828 Part 1, 9174833 Part 1, 9174833 Part 2, 9174837 Part 1, 9315328 Part 1, 9315334 Part 2, 9315339 Part 1, 9315351 Part 1, 9315355 Part 1, 9315355 Part 2, 9315387 Part 1, 9315387 Part 2, 9515007 Part 2, 9515022 Part 1, 9415022 Part 2, 9415025 Part 2, 9617605 Part 1, 9617607 Part 1, 9617615 Part 1, 9617621 Part 1, 9617623 Part 2, 9617642 Part 1, 9617642 Part 2, 9617642 Part 3, 9617643 Part 1, 9617645 Part 1;
 
6) 2101279, 2101280, 2101281, 2101282, 2101284, 2101285, 2101286, 2101287, 2101288, 2101289, 2101291, 2101292, 2101293, 2101294, 2101295, 2101297, 2101298, 2101299, 2101301, 2107132, 2107133, 2107134, 2107135, 2107136, 2107138, 2107139, 2107141, 2107142, 2107143, 2107144, 2107145, 2107147, 2107148, 2107150, 2107151, 2107154, 2107155, 2107156, 2107157, 2107158, 2107159, 2107160, 2107161, 2107162, 2115147, 2115148, 2115150, 2115151, 2115152, 2115153, 2115154, 2115155, 2115157, 2115158, 2115159, 2115160, 2115161, 2115162, 2115164, 2115165, 2115166, 2115167, 2115169, 2115170, 2115171, 2115172, 2115173, 2115174, 2115175, 2115176, 2115178, 2115179, 2115180, 2115181, 2115183, 2115184, 2115185, 2115186, 2115187, 2115189, 2115190, 2115191, 2115193, 2115194, 2115196, 6809295, 6809296, 6809297, 6809298, 6809299, 6809300, 6809301, 6809302, 6809303, 6809304, 6809305, 6809308, 6809309, 6809310, 6809311, 6809312, 6809313, 6809314, 6809315, 6809316, 6809317, 6809318, 6809321, 6809322, 6809323, 6809324, 6809325, 6809326, 6809327, 6809328, 6809329, 6810701, 6810702, 6810703, 6810704, 6810705, 6810706, 6810707, 6810708, 6810709, 6810711, 6810712, 6810713, 6810714, 6810715, 6810718, 6810720, 6812642, 6812643, 6812644, 6812645, 6812647, 6812648, 6812649, 6812650, 6812651, 6812652, 6812653, 6812654, 6812656, 6937464, 6937465, 6937466, 6937467, 6937468, 6937469, 6937470, 6937473, 6937474, 6937484, 9129389, 9129393, 9129397, 9130789, 9130791, 9130792, 9130793, 9130794, 9130795, 9130796, 9130797, 9174796, 9174800, 9174801, 9174802, 9174806, 9174807, 9174808, 9174809, 9174811, 9174813, 9174816, 9174817, 9174825, 9174831, 9174832, 9174834, 9174835, 9174836, 9174838, 9174841, 9174842, 9174843, 9174845, 9213107, 9213108, 9213109, 9213110, 9213111, 9213112, 9213113, 9213114, 9213115, 9213116, 9213117, 9213118, 9213119, 9213120, 9213122, 9213123, 9213124, 9213125, 9213131, 9213132, 9213133, 9213134, 9213135, 9213136, 9213138, 9213139, 9213140, 9213143, 9213147, 9213148, 9315321, 9315322, 9315324, 9315330, 9315331, 9315332, 9315337, 9315338, 9315348, 9315349, 9315352, 9315353, 9315354, 9315356, 9315359, 9315361, 9315362, 9315364, 9315365, 9315366, 9315368, 9315369, 9315370, 9315371, 9315374, 9315377, 9315382, 9315383, 9315385, 9315386, 9315390, 9315391, 9315394, 9315395, 9415002, 9415006, 9415009, 9415016, 9415017, 9415018, 9415019, 9415020, 9415021, 9415024, 9415026, 9415027, 9415028, 9415033, 9617606, 9617609, 9617612, 9617613, 9617614, 9617616, 9617618, 9617619, 9617620, 9617624, 9617625, 9617629, 9617630, 9617631, 9617632, 9617633, 9617635, 9617639, 9617641, 9617644, 9617646
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone and fax on January 15, 2007. Firm initiated recall is complete.
REASON
Blood products, tested for HIV and HCV using expired nucleic acid testing (NAT) reagent, were distributed.
VOLUME OF PRODUCT IN COMMERCE
754 units
DISTRIBUTION
CA, CO, FL, NE, NJ, NY, NC, TN and Switzerland
___________________________________
PRODUCT
1)Recovered Plasma. Recall # B-1431-12;
2)Red Blood Cells. Recall # B-1432-12
CODE
1) and 2) Unit: W051511122323
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by electronic notification on January 12, 2012 and by letters dated January 26, 2012 and March 13, 2012.
Manufacturer: Memorial Blood Centers, Eden Prairie, MN. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, MN
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1433-12
CODE
Unit: W036510076513 (2 units)
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by letter dated March 8, 2012. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, collected from a donor with a history of hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA, TX
___________________________________
PRODUCT
SafeTrace Tx, also rebranded as Horizon Blood Bank Haemonetics Software Solutions (formerly Wyndgate Technologies) Recall # B-1434-12
CODE
Versions 3.4.1 and 3.6.0 
RECALLING FIRM/MANUFACTURER
Haemonetics Software Solutions, El Dorado Hills, CA, by letter on March 28, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Safe Trace Tx (Horizon Blood Bank, Haemonetics Software Solutions), with a software glitch or defect that could result in an ABO incompatible blood transfusion, was distributed.
VOLUME OF PRODUCT IN COMMERCE
309 total units - 175 disks of Safe Trace Tx 3.6.0 and 3.4.1 and 134 disks of Horizon Blood Bank 3.6.0 and 3.4.1
DISTRIBUTION
Nationwide, Canada and Ethopia
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall #B-1435-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1436-12;
3) Fresh Frozen Plasma. Recall # B-1437-12
CODE
1) W037708023837 (double unit);
2) and 3) Unit: 2887867
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated February 24, 2009. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood products, collected from a donor taking the drug Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
KY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1438-12
CODE
Units: 1568988, 1567887, 1572557
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone and letter dated April 2, 2008.
Manufacturer: Shasta Blood Center, Redding, CA. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Fresh Frozen Plasma (Apheresis). Recall # B-1159-12
CODE
Unit: 2831013
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by letter dated January 23, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
Source Plasma. Recall # B-1370-12
CODE
Units: 5280090726; 5280089924; 5280089434; 5280088541; 5280088292; 5280079369; 5280077786; 5280077226; 5280076207; 5280075918; 5280073900; 5280073419; 5280072530; 5280072215; 5280070860; 5280070324; 5280069602; 5280069320; 5280068087; 5280066837; 5280066399; 5280065472; 5280065032; 5280063401; 5280062978; 5280061788; 5280061424; 5280060142; 5280059873
RECALLING FIRM/MANUFACTURER
Recalling Firm: Octapharma Plasma, Inc., Charlotte, NC, by email in July 1, 2011 and by fax on July 11,, 2011. 
Manufacturer:Octapharma Plasma, Inc., Lubbock, TX. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
CA and Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-1374-12
CODE
Units: 5280097108; 5280096381; 5280095735; 5280095064; 5280094119; 5280092998; 5280090527; 5280089927; 5280089349; 5280086609; 5280086257; 5280073513; 5280072585; 5280072158; 5280071220; 5280070821; 5280068284; 5280065435; 5280064842; 5280064086; 5280063367; 5280062745; 5280062026; 5280061396; 5280060353; 5280059936
RECALLING FIRM/MANUFACTURER
Recalling Firm: Octapharma Plasma, Inc., Charlotte, NC, by email on July 1, 2011 and by fax on July 7, 2011.
Manufacturer: Octapharma Plasma, Inc., Lubbock, TX. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1382-12
CODE
Units: 7748114, 8920717, 8920730, 7748127, 8920733, 8920735, 8920736, 7748110, 4225121, 3617160, 3617159, 7748144, 7748138, 2574131, 2574144, 2574141, 8920816, 2574218
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by facsimile on August 31, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1384-12
CODE
Unit: W141607250851
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by facsimile on October 15, 2007. 
Manufacturer: Puget Sound Blood Center, Federal Way, WA. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood product, collected from a donor whose body temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1385-12
CODE
Units: 5031769, 5032155
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by telephone on August 14, 2007, by fax on August 21, 2007. Firm initiated recall is complete.
REASON
Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AK
___________________________________
PRODUCT
Source Plasma, Recall # B-1388-12
CODE
Unit: 06DTXA9797
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services L.P., Deerfield, IL, by fax on January 16, 2007.
Manufacturer: BioLife Plasma Services, Lp, Denton, TX. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood product, collected from a donor for whom the arm inspection or general appearance of the donor was unsatisfactory, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1389-12
CODE
Units: 5280100247, 5280099055, 5280098064, 5280097516, 5280096782, 5280096161, 5280095188, 5280094564, 5280093864, 5280093146, 5280092520, 5280091719, 5280091102, 5280090493, 5280089685, 5280089051, 5280087836, 5280086972, 5280086601, 5280085863, 5280085364, 5280084579, 5280084168, 5280083549, 5280082970, 5280079238, 5280078509, 5280077022, 5280076282, 5280074145, 5280073558, 5280072508, 5280071944, 5280071243, 5280070525, 5280069425, 5280068585, 5280067994, 5280065953, 5280065041, 5280064306, 5280063423, 5280062911, 5280062025, 5280061644, 5280060821, 5280060447, 5280059625, 5280059254, 5280058522, 5280058169
RECALLING FIRM/MANUFACTURER
Recalling Firm: Octapharma Plasma, Inc., Charlotte, NC, by email and fax on July 1, 2011. Manufacturer: Octapharma Plasma, Inc., Lubbock, TX. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
51 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-1392-12
CODE
Unit: 05DTXC0503
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services L.P., Deerfield, IL, via fax on June 1, 2007.
Manufacturer: BioLife Plasma Services, LP, Denton, TX. Firm initiated recall is complete.
REASON                                                                                                                                                 
Blood product, collected from donors, whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1395-12
CODE
Unit: 084T25227
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Oakland, CA, by telephone on August 23, 2005 and by letter on September 28, 2005.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1407-12
CODE
Unit: 2915992
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone and electronic mail on December 30, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1426-12
CODE
Units: 2101290, 2101302, 2101305, 2101306, 2107140, 2107146, 2107149, 2115136, 2115149, 2115188, 2115192, 2115195, 6812658, 6937454, 6937475, 6937479, 6937485, 6937486, 9129390, 9129396, 9174820, 9213121, 9213141, 9213144, 9213145, 9213146, 9315327, 9315347, 9315367, 9414999, 9415023, 9415029, 9415035, 9617628, 9617640
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone and fax on January 15, 2007. Firm initiated recall is complete.
REASON
Blood products, tested for HIV and HCV using expired nucleic acid testing (NAT) reagent, were distributed.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
CA, CO, FL, NE, NJ, NY, NC, TN and Switzerland
___________________________________
PRODUCT
Gammagard Liquid, [Immune Globulin Intravenous (Human)], 10% Liquid, Product Code: 1502797, 20 gram, NDC Number: 0944-2700-06. Recall # B-1427-12
CODE
Unit: LE12LG70AC
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Lessines, Belgium, by letter on March 6, 2012. 
Manufacturer: Baxter Biosciences, Lessines, Belgium. Firm initiated recall is ongoing.
REASON
GAMMAGARD, misbranded with incorrect manufacturing and expiration dates, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1,601 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Source Plasma. Recall # B-1430-12
CODE
Unit: 06DTXB0724
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services L.P., Deerfield, IL, by facsimile dated December 21, 2006. 
Manufacturer: BioLife Plasma Services, L.P, Denton, TX. Firm initiated recall is complete.
REASON                                                                                                                                                
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I
___________________________________
PRODUCT
1) Elecsys Troponin I Immunoassay 05094810160. For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction. Recall # Z-1387-2012;
 
2) Elecsys Troponin I STAT Immunoassay, 05094798160. For the in-vitro quantitative determination of cardiac troponin I in human serum and plasma. Elecsys Troponin I is intended to aid in the diagnosis of myocardial infarction. Recall # Z-1388-2012
CODE
1) Lot 163176;
2) Lot: 163177
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated March 12, 2012. Firm initiated recall is ongoing.
REASON
An investigation has confirmed a considerably reduced recovery of Li-heparin plasma samples for Troponin I lot 163176 and Troponin I STAT lot 163177. In the worst case, Li-Heparin sample recovery may be as low as 50% of the serum recovery. Correct serum recovery has been confirmed for the affected lots. The issue is caused by the raw material lot (Poly-L-Lysin) instability. Poly-L-Lysin is the agent required to ensure correct recovery of Troponin I in Li-Heparin plasma samples. After the manufacturing of lot 163xxx a change to the formulation was made (a protease inhibitor was added) to further increase the already established shelf life of the reagent. Reagent lots 164xxx and higher are being manufactured with the protease inhibitor and do not exhibit reduced recovery for Li-Heparin samples.
VOLUME OF PRODUCT IN COMMERCE
3,396 (2,027 USA -Elecsys Troponin I Immunoassay: 739 kits; Elecsys Troponin I STAT Immunoassay: 1,288 kits)
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Recall # Z-1175-2012
CODE
Code numbers: H191182, H191035, H191150, H191100, H191103, H191040, H191072, H191065, H191089, H191116, H191068, H191160, H191141, H191113, H191027, H191145, H191026, H191093, H191054, H191189, H191129, H191090, H191197, H191022, H191063, H191010, H191162, H191078, H191098, H191142, H191066, H191005, H191018, H191076, H191188, H191048, H191137, H191064, H191153, H191044, H191151, H191046, H191136, H191067, H191031, H191077, H191158, H191028, H191156, H191088, H191132, H191009, H191069, H191085, H191186, H191101, H191094, H191039, H191124, H191073, H191183, H191008, H191133, H191016, H191003, H191071, H191175, H191152, H191168, H191099, H191166, H191029, H191036, H191155, H191092, H191034, H191043, H191045, H191074, H191170, H191130, H191055, H191147, H191178, H191114, H191107, H191164, H191047, H191015, H191091, H191019, H191038, H191163, H191203, H191110, H191061, H191049, H191179, H191096, H191079, H191106, H191017, H191154, H191006, H191024, H191108, H191149, H191052, H191199, H191023, H191117, H191033, H191104, H191131, H191011, H191118, H191087, H191109, H191053, H191187, H191126, H191191, H191042, H191080, H191161, H191105, H191012, H191025, H191115, H191111, H191140, H191020, H191013, H191169, H191127, H191086, H191144, H191095, H191125, H191002, H191112, H191021, H191138, H191014, H191135, H191139, H191097, H191032, H191102, H191119, H191128, H191060, H191001, H191198, H191057, H191122, H191146, H191157, H191143, H191083 H191180, H191121, H191181, H191123, H191081, H191165, H191176, H191056, H191120, H191082, H191041, H191070, H191134, H191148, H191030,H191058, H191007, H191177,H191051,H191172, H191059 and H191037
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter on January 30, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
An anomaly has been identified with the respiratory gating software of TrueBeam. When importing breath-hold gating protocols, the gating thresholds can be reset to default values, rather than retaining the thresholds established during planning.
VOLUME OF PRODUCT IN COMMERCE
182 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT. The Invacare TDX power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or non-folding type power wheelchair, with mid wheel drive capability. a) Model# TDXDP-CG, b) Model# TDXP-CG; c) Model# TDXSP-CG; d) Model# TDXSP-CG-GT; e) Model# TDXSP-CT-GT; f) Model# TDXSP-MCG. Recall # Z-1201-2012
CODE
a) Serial# 11HE001056; b)Serial# 11GE004364, 11HE000039; c) Serial# 11GE001580, 11GE001593, 11GE001874, 11GE001886, 11GE001919, 11GE001919, 11GE001920, 11GE002363, 11GE002455, 11GE002456, 11GE002464, 11GE002622, 11GE002625, 11GE002635, 11GE002839, 11GE002850, 11GE003048, 11GE003075, 11GE003249, 11GE003258, 11GE003500, 11GE003503, 11GE003687, 11GE003690, 11GE003931, 11GE003934, 11GE004230, 11GE004354, 11GE004355, 11GE004356, 11GE004359, 11GE004361, 11GE004490, 11GE004638, 11GE004642, 11HE000047, 11HE000333, 11HE000335, 11HE000343, 11HE000344, 11HE000508, 11HE000748, 11HE000749, 11HE000752, 11HE000755, 11HE000848, 11HE001057, 11HE001243, 11HE001244, 11HE001246, 11HE001311, 11HE001515, 11HE001645, 11HE001647, 11HE001653, 11HE001659, 11HE001838, 11HE001843, 11HE00756; d) Serial# 11GE001891, 11GE002134, 11GE002849, 11GE003064, 11GE003504; e) Serial# 11GE002849; f) Serial# 11GE000322, 11GE001567, 11GE001894, 11GE002136, 11GE002137, 11GE002372, 11GE002376, 11GE002377, 11GE002378, 11GE002382, 11GE002383, 11GE002385, 11GE002657, 11GE002852, 11GE003065, 11GE003067, 11GE003070, 11GE003073, 11GE003252, 11GE003261, 11GE003263, 11GE003266, 11GE003711, 11GE003712, 11GE003938, 11GE004134, 11GE004135, 11GE004368, 11HE000055, 11HE000102, 11HE000348, 11HE000511, 11HE000761, 11HE001250, 11HE001450, 11HE002071 & 11HE002523
RECALLING FIRM/MANUFACTURER
Invacare Corp., Elyria, OH, by letter dated February 10, 2012. Firm initiated recall is ongoing.
REASON
Invacare Corporation decided to recall the product because use of this actuator could result in reduced cross sectional current carrying area due to wear/chafing of the wires.
VOLUME OF PRODUCT IN COMMERCE
102 wheelchairs
DISTRIBUTION
Nationwide, Australia, Canada and New Zeeland
___________________________________
PRODUCT
1) Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Atrial and Ventricular Therapies, models D153ATG and D154ATG. The device is indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The device is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition, the device is intended to provide pacing, cardioversion, and defibrillation for treatment of patients with symptomatic, drug-refractory atrial fibrillation and/or life-threatening ventricular tachyarrhythmias. Sterile. Recall # Z-1248-2012;
 
2) Medtronic EnTrust, Single Chamber Implantable, Cardioverter Defibrillator with Ventricular Therapies, models D153VRC and D154VRC. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment for automated treatment of life-threatening ventricular arrhythmias. Sterile. Recall # Z-1249-2012;
 
3) Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Ventricular Therapies, models D153DRG and D154DRG. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment for automated treatment of life-threatening ventricular arrhythmias. Sterile. Recall #Z-1250-2012;
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, by letter beginning March 6, 2012. 
Manufacturers: Medtronic Europe Sarl, Case Postale, Tolochenaz, Switzerland;
Medtronic Puerto Rico Operations Co., Juncos, PR; 
Arizona Device Mfg, Tempe, AZ. Firm initiated recall is ongoing.
REASON
A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage.
VOLUME OF PRODUCT IN COMMERCE
68,804 devices worldwide
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems The ADVIA Centaur Vitamin D Total (Vit D) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems. The ADVIA Centaur Vit Assay is intended as an aid in the determination of vitamin D insufficiency. The ADVIA Centaur Vitamin D Diluent 2-pack is used on board the ADVIA Centaur systems to perform automatic and system-performed dilutions fro Vitamin D assay. Recall # Z-1268-2012
CODE
Lot # 80230 Expiry Date 04 May 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Healthcare Diagnostics, Inc., East Walpole, MA, by letter on February 16, 2012.
Manufacturer: Siemens Healthcare Diagnostics, Tarrytown, NY.  Firm initiated recall is ongoing.
REASON                                                                                                                                                
Automatic and system performed dilution calculation factor for Vitamin D dilutions is incorrect and causes diluted patient samples to under recover by approximately 50%.
VOLUME OF PRODUCT IN COMMERCE
442 units
DISTRIBUTION
Nationwide, Columbia, China, Denmark, Egypt, and Hong Kong
___________________________________
PRODUCT
Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking device. Recall #Z-1278-2012
CODE
Units: 2535004066, 2572002096, 2579000034, 2572000426, 2572000849, 2572002091, 2572000465, 2535004075, 2535005133, 2535005713, 2572000634, 2572000657, 2572000990, 2572001078, 2572001083, 2572001160, 2572001164, 2572001165, 2572001358, 2572001374, 2572001421, 2572001853, 2572002187, 2572003372, 2579000098, 2579000113, 2579000116, 2579000118, 2535005348, 2572001751, 2535005269, 2572000413, 2579000074, 2579000142, 2535003842, 2535003900, 2535003840, 2572002439, 2572002766, 2572003182, XXX(missing), 2579000063, 2572000759, 2572002123, 2579000069, 2572001763, 2535004162, 2572001946, 2532000044, 2535003732, 2535005475, 2572002189, 2579000151, 2579000156, 2535005551, 2535005774, 2572001705, 2579000089, 2539000224, 43203318, 2579000143, 2535004819, 2572002020, 2572002080, 2572002169, 2572002417, 2579000127, 2572000754, 2572001116, 2572001646, 2572001852, 2573000016, 2573000027, 2573000028, 2573000029, 2535004353, 2535004564, 2535004586, 2539000222, 2539000277, 2539000310, 2539000344, 2572000639, 2572001038, 2572001445, 2572001631, 2572001981, 2572002686, 2579000067, 2535005151, 2535005113, 2572002831, 2572002863, 2535005645, 2535005730, 2539000263, 2572000826, 2572002659, 2535004730, 2535005300, 2535005579, 2572000688, 2572002040, 2572002801, 2535003865, 2535004016, 2535005131, 2572002425, 2579000082, 2535004413, 2535005463, 2572000540, 2535004285, 2572003051, 2535005557, 2572003293, 2579000045, 2572000785, 2532000016, 2535004732, 2572001708, 2572002155, 2572000424, 2535004060, 2535003525, 2572000552, 2572001632, 2572002511, 2572002519, 2572001711, 2535004620, 2572001807, 2535004136, 2572002062, 2572003093, 2572001549, 2572002110, 2572002599, 2572002694, 2535005406, 2572001821, 2535004688, 2535004912, 2572000894,2572003240, 2579000090, 2539000332
RECALLING FIRM/MANUFACTURER
Permobil Inc., Lebanon, TN, by letter dated February 27, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
The fasteners used between June 3, 2011 and January 31, 2012 to attach the Permolock C3 pins to wheelchairs manufactured in the United States do not contain the required nylon ring, which allows for a more secure attachment.
VOLUME OF PRODUCT IN COMMERCE
147 units
DISTRIBUTION
Nationwide, and Australia, Canada, France, Netherlands, Sweden, and United Kingdom
___________________________________
PRODUCT
Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for gaining access to the cranium to allow for insertion and retention of intracranial cranial pressure sensor, included in the kit. Recall # Z-1279-2012
CODE
Lot Numbers: CMJB1B CMJB1C CMJB1D CMJB67 CMJB68 CMJB69 CMJB7B CMJCR6 CMJCR7 CMJCR8 CMJC1F CMJC1G CMJC1H CMJC1J CMJC1K CMJC1L CMJC1M CMKBKF CMKBKG CMKBKH CMKBK3 CMKBK4 CMKBK5 CMKBK6 CMKBK7 CMKBZ3 CMKBZ4 CMKBZ5 CMKBZ6 CMKBZ7 CMKB2Y CMKB2Z CMKB20 CMKB8L CMKCKG CMKCKH CMLBH6 CMLBMY CMLBMZ CMLBM0 CMLBM1 CMLB5P CMLB5R CMLCJR CMLCJT CMLCJV CMLC5G CMLC5H CMLC5J CMMBFR CMMBFT CMMBL5 CMMBL6 CMMCF3 CMMCF4 CMMCF5 CMMCF6 CMMC4H CMMC4J CMMC4K CMMC4L CMMC4M CMNBD9 CMNBZ4 CMNBZ5 CMNBZ6 CMNBZ7 CMNBZ8 CMNCHY CMNCHZ CMNCLW CMNCLY CMNCLZ CMNCL0 CMNCL1 CMNCL2 CMNCW5 CMNCW6 CMNCW7 CMLBJH CMMBD9 CMMCFC CMNCC1 CMNCC2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Codman & Shurtleff, Inc., Raynham, MA, by letters on February 9, 2012.
Manufacturer: Codman Sarl, Lelocle, Switzerland. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill.
VOLUME OF PRODUCT IN COMMERCE
4,056 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Terumo Advanced Perfusion System 1 Base, 100/120V, Catalog 801763, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. Indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. Recall # Z-1320-2012;
 
2)Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. Recall #Z-1321-2012
CODE
1) Lot numbers: 0011-0610, 1001-1034, 1037-1049, 1100, 1103-1445, and 1447-1449;
 
2) Lot numbers: 0006-0066, 0100-0322, 1001-1027, 1100-1434, and 1436
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letters on March 16, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Terumo CVS has received reports of 27 instances in which the 6 inch Roller Pump jammed during cardioplegia delivery.
VOLUME OF PRODUCT IN COMMERCE
1,642 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
BD BBL (tm) Lowenstein-Jensen Medium Deeps, Catalog #221256, packaged in boxes of ten/600 mL tubes. Product Usage: Lowenstein-Jensen Medium is used for the isolation and cultivation of mycobacteria. The medium tubed as deeps is used for the semi-quantitative catalase test as an aid to the classification of mycobacteria. Recall # Z-1322-2012
CODE
Lot 0091498 Exp. 10/6/11, Lot 0224698 Exp. 2/16/12, Lot 0301803 Exp. 5/3/1112, Lot 1055386 Exp. 8/30/12, Lot 1167837 Exp. 12/20/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., BD Diagnostic Systems, Sparks, MD, by letter dated January 2012. 
Manufacturer: Becton-Dickinson Diagnostics, Inc., Madison, WI. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Media fails to perform as intended with quality control organism Mycobacterium kansasii.
VOLUME OF PRODUCT IN COMMERCE
3,900 tubes
DISTRIBUTION
Nationwide, Belgium and Singapore
___________________________________
PRODUCT
1) Oridion CO2 sampling lines and water traps under the label: MicroStreamC02 Sampling Lines: FilterLine Set Adult/Pediatric -Part No: XS04620-01; FilterLine Set Adult/Pediatric (100 unit boxes)-Part No. 010579; FilterLine H Set Adult/Pediatric -Part No. XS04624 ; FilterLine H Set Adult/Pediatric (100 unit boxes) Part No: 010580; FilterLine H Set Infant/Neonatal-Part No. 006324; FilterLine Set Adult/Pediatric Long Part No. 007768; FilterLine H Set Adult/Pediatric Long Part No. 007737; FilterLine H Set Infant/Neonatal Long Part No. 007738 Smart CapnoLine Plus (O2 connector) Part No. 009818 Smart CapnoLine Plus (O2 connector) (Special 100 unit boxes) - Part No.; 010209; Smart CapnoLine Plus Long (O2 connector) Part No. 010340; Smart CapnoLine Plus Long (O2 connector) (Special 100 unit boxes) Part No: 010339; Smart CapnoLine Plus O2 (O2 tubing) Part No. 009822 Smart CapnoLine Plus O2 (O2 tubing) (Special 100 unit boxes) Part No. 010210; Smart CapnoLine Plus O2 Long (O2 tubing) Part No. 009826; Smart CapnoLine Plus O2 Long (O2 tubing) (Special 100 unit boxes) , Part No. 010341; Smart CapnoLine Pediatric Part No. 007266 Smart CapnoLine O2 Pediatric (O2 tubing) Part No. 07269; Smart CapnoLine O2 Pediatric Long (O2 tubing) Part No.007743; Smart CapnoLine H Plus O2 (O2 tubing) Part No. 010433; Smart CapnoLine H O2 Adult (O2 tubing) Part No. 010478; Smart CapnoLine H O2 Intermediate (O2 tubing) Part No; 010475; Smart CapnoLine H Pediatric (O2 connector) Part No. 010581; Smart CapnoLine H O2 Pediatric (O2 tubing) Part No. 010582 O2 CO2 Nasal FilterLine Adult (O2 connector) Part No. 010207; O2 CO2 Nasal FilterLine Adult (O2 tubing) Part No. 006912; O2 CO2 Nasal FilterLine Adult Long (O2 connector) Part No. 010342; O2 CO2 Nasal FilterLine Adult Long (O2 tubing) Part No. 007739; O2 CO2 Nasal FilterLine Pediatric (O2 tubing) Pat No. 006913; O2 CO2 Nasal FilterLine Long (O2 tubing) Part No 007740; NIV Line Adult Part No. 008174; NIV Line Pediatric Part No. 008175; Nasal FilterLine Infant/Neonatal Part No. XS0447; CapnoLine H Adult Part No. 008177; CapnoLine H Pediatric Part No. 008178; CapnoLine H Infant/Neonatal Part No. 008179; CapnoLine H O2 Adult (O2 tubing) Part No. 008180; CapnoLine H O2 Pediatric (O2 tubing) Part No. 008181; CapnoLine H O2 Infant/Neonatal (O2 tubing) Part No. 012111; VitaLine H Set Adult/Pediatric Part No. 010787; VitaLine H Set Infant/Neonatal Part No. 010807; FilterLine XL Part No. 006325; Smart CapnoLine Guardian Part No. 012528; Smart CapnoLine Guardian O2 Part No. 012529; Smart CapnoLine Guardian O2 Long Part No. 012530. Recall # Z-1332-2012;
 
2) Oridion CO2 sampling lines and water traps under the label: Surestream CO2 Sampling Lines: SureLine Adult Part No.010976; sureLine Pediatric Part No. 010977; SureLine O2 Adult Part No.010979; SureLine O2 Pediatric Part No.010980 Smart SureLine Plus O2 Adult Part No. 010981; Smart SureLine O2 Pediatric Part No. 010982; Smart SureBloc O2 Part No. 010983; Watertrap (package of 25 units) Part No. 010994; Sure VentLine Set Adult/Pediatric Part No.010986; Sure VentLine H Set Adult/Pediatric Part No.010987; Smart SureLine Guardian O2 Part No.012533; Smart SureLine Guardian O2 Long Part No.012534. Recall # Z-1333-2012;
 
3) Oridion CO2 sampling lines and water traps under the label: Omnistream CO2 Sampling Lines: OmniLine O2 Adult Part No.007609; OmniLine O2 Pediatric Part No 007610; Smart OmniLine Plus O2 Adult Part No.010177; Smart OmniLine Plus O2 Adult (package of 100 units) Part No.010213; Smart OmniLine O2 Pediatric Part No. 007606; ;Smart OmniBloc O2 Part No. 010946 Smart OmniLine Plus part No. 010172 Smart OmniLine Plus (package of 100 units) Part No 010212; Smart OmniLine Guardian O2 Part No. 012531; Smart OmniLine Guardian O2 Long Part No. 012532 OmniVentLine Set Part No. 012495. Recall # Z-1334-2012
CODE
All lots
RECALLING FIRM/MANUFACTURER
Oridion Medical 1987 Ltd., Jerusalem, Israel, by letter dated February 12, 2012. Firm initiataed recall is ongoing.
REASON
CO2 sampling lines may have paper and plastic particulate present in the packaged units at levels that may exceed visual specification.
VOLUME OF PRODUCT IN COMMERCE
6 1/2 million units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
U-SPECT-II/CT and VECTor/CT cabinet x-ray products. Laboratory research using small animals; 2 systems. Recall # Z-1335-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Milabs Bv, Utrecht, Netherlands, by letter on April 15, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
These products have doors which are not equipped with at least one safety interlock which physically disconnects power to the high voltage power supply for the x-ray source. Additionally, these products do not have a certification label and the identification labels do not include the month and year of manufacture.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN, NC
___________________________________
PRODUCT
Siemens MAGNETOM Verio Use: Nuclear resonance imaging system, Model number 10276755. Recall # Z-1364-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated March 2012. 
Manufacturer: Siemens AG, Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
During product monitoring, Siemens has discovered that the gradient cable connections on a few systems did not meet their specifications after installation. The cable connections overheated, leading to the emission of smoke and possible material damage.
VOLUME OF PRODUCT IN COMMERCE
245 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutions for intravascular administration. Pharmacy compounding system for mixing ingredients for intravascular administration. Recall # Z-1371-2012
CODE
Units: 30248; 30304; 30577; 30578; 30600; 30321; 30264; 30507; 30256; 30120; 30587; 30778; 30779; 30512; 30218; 30136; 30260; 30549; 30612; 30940; 30268; 30415; 30949; 30300; 30435; 30162; 30269; 30356; 30291;30464; 30915; 30916; 30235; 30136; 30150; 30394; 30704; 30705; 30180; 30134; 30207; 30208; 30376; 30419; 30420; 30510; 30534; 30547; 30548; 30583; 30589; 30590; 30591; 30629; 30630; 30644; 30645; 30654; 30661; 30674; 30686; 30687; 30698; 30699; 30702; 30703; 30707; 30708; 30739; 30752; 30756; 30759; 30765; 30772; 30791; 30793; 30800; 30801; 30816; 30830; 30831; 30836; 30842; 30843; 30869; 30870; 30886; 30899; 30900; 30932; 30935; 30936; 30937; 30938; 30950; 30961; 30962; 30963; 30970; 30981; 30984; 30985; 30997; 31003; 30004; 31027; 31028; 31035; 31036; 31055; 31056; 31074; 31077; 31080; 31081; 31084; 31085; 31097; 31118; 31119; 31120; 31129; 31134; 31142; 31161; 31162; 31163; 31169; 31170; 31171; 31172; 31173; 31174; 31181; 31182; 31194; 31201; 31211; 31212; 31213; 31214; 31215; 31216; 31216; 31217; 31224; 31237; 31238; 31262; 31263; 31264; 31265; 31267; 31268; 31269; 31270; 30918; 30706; 31266; 30943; 30527; 30138; 30323; 30651; 30241; 30515; 30805; 31061; 30440; 30441; 31240; 31006; 30818; 30297; 30798; 30331; 30677; 30579; 30105; 30362; 30287; 30194; 30384; 30489; 30544; 30863; 30203; 30148; 30332; 30978; 30993; 30994; 30360; 30697; 31053; 31054; 31141; 30934; 30137; 31001; 31002; 31029; 31030; 30769; 30770; 30771; 30237; 31104; 31105; 30809; 30810; 31271; 31272; 30727; 31123; 30299; 30341; 30274; 30316; 30141; 30142; 30678; 30679; 30855; 30856; 30490; 30382; 30982; 30983; 30201; 30202; 31179; 31180; 30977; 30799; 30389; 30397; 30465; 30478; 30624; 30443; 30234; 30422; 30242; 30551; 30251; 30781; 30296; 30225; 30638; 30976; 31071; 30722; 30367; 30611; 30819; 30820; 30483; 30484; 30192; 30258; 30974; 30885; 30214; 30290; 30572; 30712; 30787; 30461; 30313; 30523; 30754; 30767; 30682; 30393; 30184; 30343; 30398; 30400; 30616; 30617; 30500; 30574; 30554; 30161; 30567; 30609; 30975; 30280; 31050; 30245; 30806; 30302; 30724; 30294; 30675; 31019; 31020; 30528; 30576; 30462; 30713; 30479; 30480; 30850; 30851; 31015; 31016; 30432; 30780; 30757; 30758; 30584; 30733; 30734; 30605; 30995; 30844; 30231; 30450; 30874; 31116; 31117; 30680; 30117; 30355; 31115; 30346; 30841; 31127; 30627; 30882; 30187; 30349; 30325; 30447; 30580; 30785; 30449; 30491; 30506; 30348; 30598; 30354; 30681; 30919; 31076; 30966; 30967; 30498; 30511; 30466; 30471; 31064; 30575; 30164; 30205; 30838; 31110; 30672; 30725; 30620; 30621; 30613; 30570; 30639; 30944; 30945; 30658; 30660; 31033; 31044; 31057; 30571; 30236; 30906; 30179; 31195; 31196; 30539; 30540; 30334; 30335; 30659; 30939; 30175; 30240; 31051; 30210; 31258; 31259; 30545; 30550; 30320; 30615; 30927; 30928; 30387; 30417; 30959; 30960; 30951; 30952; 30531; 30532; 30622; 30130; 30160; 30255; 30503; 30504; 30846; 30636; 30603; 31025; 31034; 30730; 30633; 30738; 30115; 30156; 30372; 30433; 30606; 30783; 30177; 30493; 31075; 30488; 31017; 30773; 30775; 30525; 30533; 30804; 30135; 30267; 30340; 30463; 30894; 30941; 30889; 30481; 30494; 30709; 30796; 30872; 30381; 30890; 30876; 30198; 30157; 30229; 30526; 30111; 30273; 31072; 31073; 30634; 30723; 30221; 30296; 30676; 31018; 30835; 30803; 30811; 30924; 30905; 30641; 30642; 30149; 30216; 30595; 30128; 30188; 30185; 30524; 30563; 30152; 30270; 30306; 30505; 31207; 31208; 30369; 30254; 30406; 30497; 30784; 31111; 30469; 30826; 30519; 30520; 30541; 30625; 30688; 31151; 30535; 30536; 30986; 30987; 30197; 30247; 30486; 30592; 31112; 31012; 30305; 30475; 30379; 30812; 31239; 30619; 30343; 30223; 30288; 30366; 30217; 30700; 30174; 30263; 30314; 30685; 30308; 30209; 30204; 30412; 30315; 30378; 30345; 30789; 30508; 30653; 31159; 31160; 30908; 30499; 30683; 31065; 30448; 30477; 30807; 30808; 30742; 30139; 30902; 30903; 31274; 31275; 30664; 30648; 31234; 30485; 30743; 30762; 30763; 30439; 31176; 31177; 30423; 31008; 30565; 30250; 30988; 30989; 30607; 30696; 30509; 30181; 30999; 31000; 30113; 30392; 30404; 30582; 30953; 30414; 30614; 30802; 30892; 30893; 30646; 30259; 30338; 30361; 30405; 30409; 30650; 30145; 30119; 30319; 30109; 31125; 31247; 31248; 30454; 30455; 30719; 30168; 31197; 31198; 30102; 30118; 30887; 30888; 30166; 30167; 30942; 30170; 30626; 30839; 31070; 30468; 30735; 30879; 30881; 30410; 30649; 30909; 30425; 60456; 31078; 31079; 31158; 30750; 30751; 30790; 30200; 31058; 30555; 60556; 30792; 30721; 30618; 30640; 30213; 30310; 30979; 30980; 30964; 30965; 30690; 30647; 30637; 30797; 30521; 30522; 30923; 30322; 30327; 30155; 30232; 30363; 30413; 30849; 30744; 30760; 30821; 30822; 31164; 31249; 31250; 30729; 30858; 30513; 30514; 30529; 30530; 30666; 30667; 30823; 30827; 31100; 30276; 30643; 30342; 30428; 30749; 30153; 30178; 30632; 30635; 30837; 30838; 30560; 30561; 30452; 30453; 30552; 30710; 30401; 30459; 31218; 31219; 30593; 30776; 30176; 30817; 30238; 30239; 30399; 30282; 30782; 30910; 30917; 30265; 30954; 31143; 31144; 30222; 30446; 30657; 30460; 31095; 31031; 31191; 31192; 31149; 30476; 30546; 30227; 30228; 30921; 30922; 30968; 30969; 30144; 30581; 31220; 31221; 31222; 31223; 30226; 30227; 31228; 31230; 31251; 31252; 31253; 31254; 31037; 31038; 31039; 31040; 31041; 31042; 31043; 31045; 31046; 31047; 30693; 30764; 31204; 31205; 31206; 30599; 31145; 31146; 31147; 31148; 31150; 31152; 31153; 31154; 30277; 30492; 30873; 31114; 31005; 31007; 31009; 30114; 30129; 30189; 30328; 30768; 30336; 30585; 31260; 31261; 31087; 31088; 31089; 31090; 31091; 31092; 31093; 31094; 31052; 30601; 30602; 30753; 30122; 30233; 30261; 30788; 30487; 30257; 30861; 30815; 30946; 30226; 30411; 30445; 31010; 30929; 30930; 30430; 30692; 30777; 30230l 31165; 31175; 30329; 30652; 30897; 30898; 30196; 30373; 30182; 30673; 30467; 30597; 30746; 30761; 30472; 31026; 30337; 31062; 31063; 30691; 31121; 30852; 30853; 30374; 30990; 30991; 30971; 30972; 31059; 31060; 30326; 30845; 30813; 31032; 30731; 30732; 30121; 30402; 30668; 30669; 30867; 30868; 30913; 30914; 30370; 30371; 30586; 30588; 30252; 30496; 30594; 30711; 30907; 30391; 30665; 30948; 30748; 30862; 30863; 30127; 31094; 30840; 30243; 30364; 30365; 30235; 30755; 30891; 30517; 30518; 31255; 31256; 30542; 30568; 30281; 30747; 30786; 30537; 30538; 30539; 30726; 30718; 30143; 30824; 30825; 30303; 30694; 30631; 30165; 30737; 30925; 30926; 30333; 30429; 30474; 30794; 30795; 31048; 31848; 30470; 30124; 30864; 30357; 30442; 30623; 30295; 30857; 30878; 30716; 30717; 31103; 30502; 30911; 30912; 31183; 31184; 31186; 31187; 31188; 31225; 30955; 30956; 30318; 30957; 30958; 30834; 30847; 31021; 30559; 30286; 30662; 30663; 31209; 31210; 30740; 30741; 30173; 30195; 31123; 30159; 30163; 30655; 30656; 30358; 30684; 30875; 30877; 30998; 30901; 30436; 31199; 31200; 30407; 30610; 30278; 30418; 30896; 30458; 30101; 30317; 30720; 31229; 31231; 31139; 31140; 30116; 30151; 30173; 30865; 30271; 30895; 30828; 30829; 31022; 31023; 30124; 30344; 30421; 31126; 30132; 30133; 30112; 30253; 31067; 31068; 31185; 30206; 30564; 30880; 30569; 31156; 31157; 31113; 30147; 30171; 30301; 30244; 30285; 30604; 30832; 30833; 30883; 30396; 31108; 31166; 31167; 31168; 30390; 30566; 30158; 30884; 30339; 30292; 31106; 31107; 31189; 31190; 31109; 31135; 31136; 31137; 31138; 30562; 30933; 30596; 30211; 30854; 30860; 31241; 31242; 31243; 31244; 31245; 31246; 30871; 30131; 30859; 31130; 31131; 30293; 30243; 30244; 30110; 30191; 30219; 30714; 30996; 31124; 30154; 31013; 31014; 30108; 31132; 31133; 31098; 31099; 30557; 31066; 31122; 31178; 31257; 31233; 30543; 30106; 31102; 30330; 30424; 31082; 31083
RECALLING FIRM/MANUFACTURER
Baxa Corp., Englewood, CO, by letter dated June 3, 2008. Firm initiated recall is ongoing.
REASON
Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the EM 2400.
VOLUME OF PRODUCT IN COMMERCE
1000 units (approximately)
DISTRIBUTION
Nationwide, Australia, Canada, China, New Zeland, and UK
___________________________________
PRODUCT
1) CDI Blood Parameter Monitoring System 500, 500AVHCT. Intended for use during cardiopulmonary bypass procedures. Recall # Z-1378-2012;
 
2) CDI Blood Parameter Monitoring System 500, 500AHCT. Intended for use during cardiopulmonary bypass procedures. Recall # Z-1379-2012;
 
3) CDI Blood Parameter Monitoring System 500, 500AV. Intended for use during cardiopulmonary bypass procedures. Recall # Z-1380-2012;
 
4) CDI Blood Parameter Monitoring System 500, 500A. Intended for use during cardiopulmonary bypass procedures. Recall # Z-1381-2012;
 
5) CDI Blood Parameter Monitoring System 500, 500V. Intended for use during cardiopulmonary bypass procedures. Recall # Z-1382-2012
CODE
1) 500AVHCT CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/ Saturation probe: 1001, 1005, 1007, 1011-1022, 1024, 1028, 1032, 1036, 1038, 1039, 1041-1044, 1046, 1047, 1049-1053, 1059, 1063, 1066-1071, 1075, 1096, 1097, 1101, 1103-1105, 1111-1113, 1115, 1130, 1133-1140, 1146-1152, 1166-1168, 1181-1185, 1216-1220, 1231-1235, 1244-1248, 1254, 1255, 1261-1264, 1270-1274, 1285, 1286-1289, 1295-1299, 1304-1309, 1312-1315, 1321, 1332-1334, 1340-1344, 1350-1354, 1357, 1358, 1379-1383, 1389-1393, 1399-1408, 1414-1418, 1421, 1422, 1424-1433, 1439-1443, 1449-1453, 1459-1463, 1466, 1479, 1480, 1494, 1525, 1554, 1597-1601, 1605, 1617-1631, 1637-1646, 1657-1661, 1672-1676, 1682-1686, 1697-1701, 1712-1716, 1733-1737, 1787-1789, 1805-1809, 1815-1819, 1830, 1844-1846, 1857-1860, 1886-1890, 1901-1905, 1916-1920, 1926-1930, 1936-1940, 1953-1974, 1976-1985, 2028-2034, 2036-2038, 2040, 2045, 2059-2063, 2065-2067, 2070-2077, 2086, 2097-2101, 2109-2111, 2113-2115, 2123-2131, 2138-2142, 2149-2155, 2177-2182, 2185-2187, 2189, 2195-2199, 2214, 2216-2219, 2224, 2228-2231, 2243-2245, 2249-2253, 2255-2258, 2260, 2263, 2265-2268, 2275-2277, 2279, 2285-2291, 2295-2298, 2313-2321, 2323-2329, 2338-2354, 2357, 2368, 2370-2375, 2377, 2392, 2403-2408, 2417-2426, 2432-2436, 2439-2444, 2453-2458, 2463-2467, 2470-2472, 2476-2483, 2487-2503, 2514-2517, 2521-2525, 2541-2556, 2565-2582, 2587-2603, 2629-2633, 2635-2642, 2646, 2647, 2656, 2661, 2662, 2664-2680, 2689-2691, 2695, 2696, 2701-2708, 2710-2716, 2722-2727, 2737, 2742-2747, 2757-2773, 2783, 2784, 2788, 2793-2795, 2802, 2805-2808, 2815-2820, 2837-2839, 2846-2849, 2865-2870, 2880-2889, 2892-2895, 2906-2908, 2913-2915, 2920, 2921, 2924-2926, 2937-2940, 2942-2947, 2952, 2958-2975, 2979-2983, 2990-2999, 3008-3010, 3022-3027, 3040, 3041, 3052-3055, 3073-3075, 3083-3087, 3096, 3115, 3116, 3139-3145, 3152, 3153, 3155-3162, 3169-3182, 3190-3196, 3214-3220, 3225-3228, 3232, 3238-3245, 3248, 3249, 3264-3268, 3287, 3288, 3291-3306, 3314-3323, 3329-3334, 3340-3349, 3354-3357, 3369-3373, 3383-3391, 3394-3397, 3402-3406, 3416, 3418-3427, 3434-3437, 3441-3447, 3449-3456, 3458-3462, 3469-3472, 3481, 3482, 3489, 3490, 3500-3503, 3509, 3510, 3518, 3534, 3535, 3541-3545, 3571-3573, 3590-3609, 3612-3619, 3624-3628, 3636-3639, 3643-3645, 3669-3681, 3698-3703, 3715, 3716, 3722-3726, 3738-3744, 3753-3757, 3769-3780, 3784-3787, 3799-3804, 3811-3816, 3827-3830, 3838-3841, 3852-3881, 3892-3899, 3902-3906, 3912-3921, 3924-3931, 3937-3952, 3962-3965, 3971-3974, 3986-3989, 3995-3998, 4006-4029, 4038-4043, 4050-4055, 4070-4075, 4082-4089, 4096-4099, 4105-4108, 4114-4131, 4143-4148, 4169-4185, 4203-4212, 4219-4224, 4230-4241, 4260-4280, 4290-4299, 4307-4310, 4318-4323, 4335-4344, 4351, 4352, 5001-5010, 5036-5039, 5048-5056, 5065-5077, 5082-5085, 5094-5101, 5118-5125, 5142-5149, 5158-5169, 5178, 5179, 5190, 5197, 5198, 5210-5213, 5222-5225, 5238-5245, 5250-5253, 5274-5277, 5282-5285, 5290-5293, 5298-5305, 5318-5321, 5334-5337, 5341-5344, 5354-5356, 5370-5374, 5383, 5385, 5386, 5516-5526, 5532-5541, 5557-5561, 5584-5587, and 5589-5592;
 
2) 500AHCT CDI Blood Parameter Monitoring TBD System 500 with Arterial blood parameter module and Hematocrit/ Saturation probe: 1023, 1025-1027, 1029-1031, 1034, 1035, 1037, 1040, 1045, 1048, 1054-1058, 1060-1062, 1064, 1065, 1072-1074, 1076-1095, 1098-1100, 1102, 1106-1110, 1114, 1116-1129, 1131, 1132, 1141-1145, 1153-1165, 1169-1180, 1186-1191, 1194-1210, 1212-1215, 1221-1230, 1236-1243, 1249-1253, 1256-1260, 1265-1269, 1275-1284, 1290-1294, 1300-1303, 1310, 1311, 1316-1320, 1322-1331, 1335-1339, 1345-1349, 1359-1378, 1384-1388, 1394-1398, 1409-1413, 1419, 1434-1438, 1444-1448, 1454-1458, 1469-1478, 1481, 1482, 1484-1493, 1495-1503, 1505-1520, 1528, 1531-1553, 1555-1558, 1567-1596, 1607-1616, 1632-1636, 1647-1656, 1667-1671, 1677-1681, 1687-1696, 1702-1711, 1717-1721, 1728-1732, 1738-1753, 1759-1775, 1777-1786, 1790-1794, 1796-1804,1810-1814, 1820-1829, 1831-1843, 1847-1850, 1856, 1861-1885, 1891-1900, 1906-1915, 1921-1925, 1931-1935, 1941-1950, 1975, 1986-2015, 2017-2022, 2024-2027, 2039, 2041-2044, 2046-2058, 2064, 2068, 2069, 2078-2085, 2087-2096, 2108, 2116, 2118-2122, 2132-2137, 2143- 2148, 2156-2176, 2183, 2184, 2188, 2191-2194, 2200-2213, 2215, 2220-2223, 2225-2227, 2232-2242, 2247, 2248, 2254, 2259, 2261, 2262, 2264, 2269-2272, 2278, 2280-2284, 2292-2294, 2299-2312, 2330-2337, 2353, 2359-2363, 2376, 2378-2388, 2398-2402, 2409-2416, 2427-2431, 2437, 2438, 2445-2452, 2459-2462, 2468, 2469, 2473-2475, 2484-2486, 2505-2513, 2518-2520, 2526-2540, 2557-2564, 2583-2586, 2604-2628, 2643-2645, 2648-2655, 2657-2660, 2663, 2681-2688, 2692-2694, 2697-2699, 2709, 2717-2721, 2728-2736, 2738-2741, 2748-2756, 2774-2782, 2785-2787, 2789-2792, 2796-2799, 2803, 2809-2814, 2821-2836, 2840-2845, 2850-2859, 2861-2864, 2871-2879, 2896-2900, 2903-2905, 2909-2912, 2916-2919, 2922, 2923, 2927-2936, 2941, 2948-2951, 2953-2957, 2976-2978, 2984-2989, 3000-3007, 3014-3021, 3028-3039, 3042-3051, 3056-3072, 3076-3082, 3088-3095, 3097-3114, 3117-3124, 3126-3130, 3136-3138, 3147-3151, 3154, 3163-3168, 3183-3189, 3197-3213, 3221-3224, 3229-3231, 3233-3237, 3246, 3247, 3250-3260, 3269-3286, 3290, 3307-3313, 3324-3328, 3335-3339, 3350-3353, 3358-3368, 3374-3382, 3392, 3393, 3398-3401, 3407-3409, 3411-3415, 3428-3433, 3438-3440, 3448, 3457, 3463-3468, 3473-3479, 3483-3488, 3491-3499, 3504-3508, 3511-3517, 3519-3533, 3536-3540, 3546-3570, 3574-3589, 3610, 3611, 3620-3623, 3632-3635, 3640-3642, 3649-3660, 3662-3668, 3682-3697, 3704-3714, 3717-3721, 3727-3737, 3745-3752, 3758-3768, 3781-3783, 3788-3798, 3805-3810, 3817-3826, 3831-3837, 3842-3851, 3882-3891, 3900, 3901, 3907-3911, 3922, 3923, 3932-3936, 3953-3961, 3966-3970, 3975-3985, 3990-3994, 3999-4005, 4030-4037, 4044-4049, 4056-4069, 4076-4081, 4090-4095, 4100-4104, 4109-4113, 4133-4142, 4149-4168, 4186-4202, 4213-4218, 4225-4229, 4242-4259, 4281-4289, 4300-4306, 4311-4317, 4324-4334, 4345-4350, 4353-4371, 5011-5035, 5040-5047, 5057-5064, 5078-5081, 5086-5093, 5102-5117, 5126-5141, 5150-5157, 5170-5177, 5180-5189, 5191-5196, 5199-5209, 5214-5221, 5226-5237, 5246-5249, 5254-5273, 5278-5281, 5286-5289, 5294-5297, 5306-5317, 5322-5329, 5345-5348, 5350-5353, 5358-5369, 5375-5382, 5387, 5388, 5500-5515, 5527-5531, 5542-5556, 5562-5564, 5566, 5569, 5571, 5572, 5574-5577, 5581-5583, and 5593-5600;
 
3) 500AV CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules: 1192, 1193, 1355, 1356, 1420, 1423, 1464, 1465, 1467, 1468, 1483, 1504, 1521-1524, 1526, 1527, 1529, 1530, 1602-1604, 1606, 1662, 2023, 2035, 2102-2107, 2800, 2901, 2902, 3131-3135, 3261, 3262, 4132, 5330-5333, 5338-5340, and 5579;
 
4) 500A CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module: 1211, 1559-1563, 1663-1666, 1722-1727, 1754-1758, 1776, 1795, 1951, 1952, 2016, 2112, 2117, 2190, 2246, 2273, 2274, 2322, 2355, 2356, 2389-2391, 2393, 2394, 2397, 2634, 2700, 2801, 2804, 2860, 2890, 2891, 3011-3013, 3125, 3146, 3263, 3289, 3410, 3417, 3480, 3629-3631, 3646-3648, 3661, and 5349;
 
5) 500V CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module: 1564-1566.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter on February 3, 2012.
Manufacturer: Terumo Cardiovascular Systems Corp., Ann Arbor, MI. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.
VOLUME OF PRODUCT IN COMMERCE
3,829 Units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation. Recall # Z-1395-2012
CODE
Units: C11H25B C11H25C C11H25D C11H29E C11H29F C11H29G C11J06A C11J06B C11J06C C11J06D C11J12A C11J12B C11J21E C11J22F C11J29A C11J29B C11J29C C11K03E C11K06A C11K06B C11K06C F11J19A F11J29F F11K11D F11K25G F11L03A and F11L17A
RECALLING FIRM/MANUFACTURER
Spectranetics Corp., Colorado Springs, CO, by letter on March 14, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.
VOLUME OF PRODUCT IN COMMERCE
615 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
PFC Steinman Pin/Drill Pack Sterile (WPC 667-2012) Drill Bit and Steinman Pin Packet (1 unit) The PFC Steinman Pin/Drill Pack Sterile is part of the PFC Modular Knee Instrument system. The single pack (1 box) contains 2 pieces of 1/8 Target Drill Bit product code 513-4193-01 and 4 pieces of Steinman Pin product code 086-9117-00. The Drill Bits are 0.125 in diameter and 5 long. The Steinman Pins in this pack are 0.125 in diameter and 3 long. The pack is provided sterile to the customer and is intended for one time use. The contents of the pack provide stable fixation of the femoral or tibial cutting blocks to the bone while a cut is made. Product code: 864192. Recall # Z-1426-2012
CODE
 Lot: 167026,167034, 167035
RECALLING FIRM/MANUFACTURER
DePuy Orthopaedics, Inc., Warsaw, IN, by letter dated March 12, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Sterility of the pins is at risk because product packaging, which is designed to include 2 pouches (innerpouch and ourter pouch) around the pin mounting card only, contains a single pouch, which could compromise product sterility.
VOLUME OF PRODUCT IN COMMERCE
63 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Hudson RCI, BiteGard Oral Bite Block, Single Patient Use, Rx Only. The Teleflex Medical BiteGard Molar Bite Black is a disposable single patient use device that fits between the patients molars to prevent the patient from closing their mouth entirely and from obstructing the Laryngeal Mask Airway (LMA) tube, in the case where one is used. a) Catalog number: 1140; Catalog number: 41140 (sold internationally). Recall # Z-1427-2012
CODE
a) Lot numbers: 02A0800905, 02C1100483, 02F1000054, 02J0902663, 02A0801994, 02C1101954, 02F1000055, 02J1000939, 02A1000256, 02C1102754, 02F1100700, 02J1001824, 02A1000257, 02D0800059, 02F1101638, 02J1001825, 02A1001314, 02D0801329, 02G0801052, 02K0801935, 02A1001766, 02D0900557, 02G0802642, 02K0803847, 02A1100326, 02D0901732, 02G0900707, 02K0803848, 02A1101331, 02D1100098, 02G0901295, 02K0803849, 02A1102273, 02E0800110, 02G0902610, 02K0900029, 02B0900298, 02E0800342, 02G1000387, 02K0901174, 02B1000808, 02E0802363, 02G1000547, 02K1000019, 02B1000809, 02E0900148, 02G1100211, 02K1000520, 02B1001744, 02E0900638, 02H0800052, 02L1000392, 02B1100389, 02E1000111, 02H0800366, 02L1002223, 02B1101712, 02E1001758, 02H0801439, 02M0900100, 02C0800010, 02E1002588, 02H0801440, 02M0900855, 02C0802808, 02E1100223, 02H0900911, 02M0901463, 02C0901197, 02E1101181, 02J0800358, 02M0902072, 02C1001856, 02F0801932, 02J0801231, 02M1000288, 02C1001857, 02F0900762, 02J0900815 and 02M1000824 and b) Lot numbers: 02A1102347, 02C1000226, 02C1003651, 02C1100970, 02D1001954, 02D1002705, 02D1101766, 02E1000107, 02E1100311, 02G0900700, 02J0802603, 02J1001026, 02K0901769, 02K1000616, 02K1001588, 02L0901972 and 02L1000486
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Research Triangle Park, NC, by letters on or about April 3, 2011.
Manufacturer: Teleflex Medical, Nueva Laredo, Mexico. Firm initiated recall is ongoing.
REASON                                                                                                                                                
The bite block can become separated from the handle. If separation occurs, medical intervention may be required to remove the bite block from the patient's trachea or esophagus/GI tract.
VOLUME OF PRODUCT IN COMMERCE
333,724 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Panta� Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted within an instrumentation tray. The product is available in six (6) sizes. All nails are color-coded for easy size identification. Bony fixation is achieved using two (2) tibial screws, two (2) calcaneal screws and one (optional) talar screw. The nail, cross-locking screws and end cap are manufactured from a titanium alloy: TI-6AI-4V ELI ISO 5832-3, ASTM F136. The PANTA Arthrodesis Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. The Panta� Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: " Post-traumatic and degenerative arthritis involving both ankle and subtalar joints. " Rheumatoid arthritis. " Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body. " Revision of failed total ankle arthroplasty with subtalar intrusion. " Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis). " Avascular necrosis of the talus. " Neuroarthropathy or neuropathic ankle deformity. " Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease. " Severe pilon fractures with trauma to the subtalar joint. Model #519110. Recall # Z-1428-2012
CODE
Batch Numbers: E5PS, E7D8, E6QU/1, E1LV, E43W, E1LV/1, E698, E1RR, E43W/1, EJZR, E1LQ, E698/1, and E7D8/1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by letter and E-mail on May 19, 2011. 
Manufacturer: NewDeal SA, Lyon, France. Firm initiated recall is ongoing.
REASON                                                                                                                                                
The firm received multiple complaints from their user customers (surgeons) who reported encountering difficulty inserting a calcaneal or tibial screw through the holes of the PANTA nail.
VOLUME OF PRODUCT IN COMMERCE
64 units
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Norco Folding Shower Bench; Features a nonskid surface and handholds for added security. Holes allow excess water to drain away easily. Sturdy legs have non-skid rubber feet. Supports up to 200 lbs. Comfort and safety in shower. Model NC87102. Recall # Z-1429-2012
CODE
All units.
RECALLING FIRM/MANUFACTURER
Recalling Firm: North Coast Medical Inc., Gilroy, CA, by letter dated March 20, 2012.
Manufacture: Apex Medical Corp., Tucheng City, Taipei County, Taiwan. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Due to a consumer complaint, North Coast Medical determined that due to a design flaw, there was not enough plastic support material to retain bracket bolts when subjected to a force greater than 150 lbs.
VOLUME OF PRODUCT IN COMMERCE
370 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista(R) System. Recall # Z-1433-2012
CODE
Lot numbers: 11263AC, 11286AB, 11306BA, 11332AB, 11332AC and 12010AB
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated February 5, 2012.
REASON                                                                                                                                                 
Firm has confirmed a negative shift of approximately 0.2mg/dL [0.08 mmol/L] in patient and QC samples when using Vista Magnesium.
VOLUME OF PRODUCT IN COMMERCE
9,178 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
MEDPOR PLUS SST EZ 22mm Sphere Implant. MEDPOR PLUS Orbital Implants are intended to restore the volume of an enucleated or eviscerated eye globe. Catalog number: 80062. Recall # Z-1435-2012
CODE
Lot Codes: F000689 and G004528
RECALLING FIRM/MANUFACTURER
Howmedica Osteonics Corp dba Stryker Craniomaxillofacial, Newnan, GA, by letter on March 20, 2012 and on March 26, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
CA, GA, IL, MA, MI, MS, NY, PA, OR and TX
___________________________________
PRODUCT
Boston Scientific LATITUDE� Patient Management System Communicator, Model 6476. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. Recall # Z-1445-2012
CODE
Units: 219329, 218900, 219316, 219304, 219367, 219372, 218958, 218842
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific CRM Corp., Saint Paul, MN, via telephone starting on February 24, 2012, or letter dated February 29, 2012.  
Manufacturer: Plexus Electronic Assembly, Bayan Lepas, Malaysia. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Patient Management System Communicators were shipped to the incorrect patients.
VOLUME OF PRODUCT IN COMMERCE
8 unts
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps. Recall # Z-1450-2012
2) Sarns Modular Perfusion System 8000 Catalog number 16413 Arterial Monitor The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps. Recall # Z-1451-2012;
3) Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3 Temperature-Pressure Board, Cardioplegia Monitor (service part only) The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps. Recall # Z-1452-2012;
 
4) Sarns Modular Perfusion System 8000 Catalog number 149112 or 78-8067-4840-2 Temperature-Pressure Board, Arterial Monitor (service part only) The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps. Recall # Z-1453-2012
CODE
1) Lot/serial numbers: PT001*, 1001-1064, 1070-1146, 1148-1220, 1222-1227, 2000-2039, 2045-2059, 2061- 2064, 2100-2157, 2159-2203, 2205-2335, 2337-2399, 2401-2408, 3000-3014, 3016-3070, 3072-3110, 3112-3385, 3387-3558, and 3560-3840;
 
2) Lot numbers/serial numbers: PT003*, 1001-1079, 1085-1270, 1276,2000-2013,2015-2028, 2030-2109, 2111-2295, 2297-2396, 2398-2433, 2435-2439, 3000-3020, 3022-3052, 3054-3065, 3067-3104, 3106-3197, 3199-3211, 3213-3593, 3595-3634, 3636-3827, and 3829-3908;
 
3) Lot numbers/serial numbers: 1, 2, 3, 246546, 249510, 249511, 249647, 254871, 258279, 263615, 270671, 273712, 274258, 278324, 280640, 285001, 290027, 294434, 295965, 301085, 305999, 308323, 316251, 320749, 325181, 326988, 329131, 332078, 332292, 333714, 336835, 337478, 340618, 343974, 348433, 355116, 355594, 358380, 362038, 363388, 367158, 375588, 379930, 381111, 385518, 389149, 392758, 393294, 400090, 400091, 401120, 401121, 401127, 401832, 401885, 402285, 402404, 403219, 403611, 403717, 404052, 404360, 404929, 405141, 405324, 405558, 405569, 405719, 405855, 406498, 406716, 406781, 407341, 407342, 407501, 407639, 407793, 408201, 408359, 408600, 409098, 409104, 409291, 409302, 409570, 409755, 410056, 411301, 411699, 412209, 413388, 413575, 413992, 414974, 415022, 415379, 415605, 415844, 416787, 418180, 418289, 418482, 418915, 419276, 419555, 419935, 420558, 420782, 420850, 421705, 421939, 421941, 422214, 422498, 422990, 423664, 425424, 428898, 435660, 439119, 441511, 443513, 447675, 448720, 453531, 457904, 461150, 463168, 466017, 467449, 469356, 478255, 479117, 483184, 483633, 487810, 91429006, 93323004, 93355004, 93355005, 94025004, 94095004, 94095005, 94116005, 94129005, 94129006, 94143005, 94143006, 94186005, 94186006, 94200005, 94200006, 94207006, 94221006, 94256006, 94283006, 94290006, 94297006, 94304006, 94322006, 94339006, 95009006, 95048006, 95061006, 95072006, 95093006, 95101006, 95108006, 95114006, 95124006, 95179006, 95194006, 95219006, 95265006, 95279006, 95300006, 95310006, 95339006, 95363006, 96036006, 96086006, 96102006, 96113007, 96143008, 96162008, 96187008, 96193008, 96200008, 96236008, 96250008, 96262008, 96277008, 96295008, 96316008, 96331008, 96338008, 96348008, 96353008, 97006008, 97007008, 97015008, 97017008, 97073008, 97122008, 97133008, 97139008, 97161008, 97168008, 97175008, 97223008, 97238008, 97252008, 97279008, 97286008, 97300008, and W417301;
 
4) Lot numbers/serial numbers: 1, 2, 3, 246553, 249652, 253943, 256867, 258565, 263614, 269567, 276866, 279012, 281191, 288150, 290070, 296227, 298374, 303142, 308343, 309896, 320618, 323004, 325187, 327295, 329342, 330149, 331788, 333055, 335139, 337482, 341259, 343978, 349845, 352311, 355122, 358382, 358383, 360213, 367161, 370516, 376523, 378092, 381115, 383781, 389150, 392116, 395215, 400085, 400086, 400833, 401042, 401570, 401675, 402124, 402264, 403141, 403142, 403545, 403712, 403719, 404180, 404359, 405057, 405333, 405712, 405859, 406219, 406366, 406512, 406717, 407049, 407241, 407338, 407620, 407637, 407813, 407902, 408362, 408526, 408666, 409214, 409283, 409297, 409422, 409571, 410057, 410250, 410397, 411130, 411208, 411295, 411563, 412058, 412213, 412890, 413161, 413182, 414317, 414363, 414815, 415034, 415250, 415670, 416854, 417128, 417433, 417435, 417561, 418217, 418779, 418911, 419146, 419556, 420313, 420687, 421632, 421834, 422083, 422739, 423663, 424267, 426877, 429622, 430398, 438156, 439123, 444234, 445779, 448180, 452751, 455760, 458517, 461157, 463964, 467455, 468739, 479124, 483205, 483635, 487380, 9434006, 93326004, 94059004, 94115004, 94123004, 94123005, 94130005, 94143005, 94143006, 4158005, 94175005, 94179005, 94179006, 94186005, 94186006, 94200005, 4200006, 94206005, 94206006, 94234006, 94249006, 94284006, 94297006, 94304006, 94311006, 94318006, 95006005, 95048006, 95059006, 95067006, 95086006, 95094006, 95108006, 95114006, 95122006, 95171006, 95174006, 95215006, 95223006, 95234006, 95244006, 95265006, 95282006, 95305006, 95312006, 95345006, 95356006, 96043006, 96091 006, 961 03006, 961 08006, 96143008, 96158008, 96162008, 96200008, 96228008, 96236008, 96241008, 96253008, 96277008, 96295008, 96313008, 96344008, 96348008, 96353008, 97004008, 97006008, 97007008, 97052008, 97066008, 97087008, 97113008, 97120008, 97132008, 97141008, 97156008, 97157008, 97161008, 97199008, 97223008, 97230008, 97238008, 97261008, 97279008, 97302008, and 97308008
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter on March 21, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Terumo received multiple reports of malfunctions of the Cardioplegia and arterial monitors for the Sarns Modular Perfusion System 8000. Upon review of complaint investigation, the malfunctions are caused by or could have been caused by soldering anomalies on the circuit board of the monitor. The compromised solder joints could cause intermittent or loss of display, or could cause monitor reset, potentially resulting in a stopped pump or pumps.
VOLUME OF PRODUCT IN COMMERCE
3,022 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Siemens Healthcare Diagnotics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista(R) chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensory technology for clinical use. Recall # Z-1454-2012
CODE
Vista software version 3.4
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark. DE, by letter dated December 19, 2011 and on January 16, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Siemens has confirmed customer complaints on Vista(R) software version 3.4 for Below Manufacturer Assay Range error flags associated with QC and patient test results that are within the assay range as defined in the Instructions For Use for the respective method. This issue is isolated to Vista(R) software version 3.4. Customers who have not made any changes to the default method configurations are not affected. Other versions of Vista(R) are also not affected.
VOLUME OF PRODUCT IN COMMERCE
1,683 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Quintex Cervical Plating System - Screws. The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability. The Quintex Cervical Screws are available in three different versions: a) semi-constrained, b) constrained, and c) dynamic. The screws all have a head diameter of 4.0mm and vary in length from 10mm to 22mm. Rescue screws are also available with a 4.5mm head diameter and lengths of 11-19mm. The screws are part of the Quintex Cervical Plating System. Recall # Z-1455-2012
CODE
a) Lot # SC400T - SC406T and SC490T - SC494T; b) SC500T - SC506T and SC590T - SC594T; c) SC600T - SC606T and SC690T - SC694T; all distributed lot numbers and serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aesculap Implant Systems, Center Valley, PA, by letter on January 20, 2012.
Manufacturer: Aesculap AG, Tuttlingen, Germany. Firm initiated recall is ongoing.
REASON                                                                                                                                                
The locking ring that sits in the head of the screw can come out of the screw head when engaged with the screwdriver if the screwdriver is improperly angled.
VOLUME OF PRODUCT IN COMMERCE
891 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Philips Digital Diagnost Systems with Eleva software version 2.x and stitching option Intended use: Stationary radiographic system, Radiographic system, digital. Model #s 712020, 712022, 712082. Recall # Z-1464-2012
CODE
All systems with Eleva software version 2.x and stitching option.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated March 30, 2012.
Manufacturer: Philips Medical Systems Gmbh, DMC, Development and Manufacturing Ctr., Hamburg, Germany. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Potential misdiagnosis due to improperly automatically stitched images improper image ruler handling.
VOLUME OF PRODUCT IN COMMERCE
606 units (153 units nationwide and 453 units international)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT  
1) Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure, an aid in the risk stratification of patients with heart failure, and as an aid in the risk stratification of patients with acute coronary syndromes. Recall # Z-1466-2012;
 
2) Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes. Recall # Z-1467-2012
CODE
1) Lot Code: W49569;
2) Lot Code: W48990
RECALLING FIRM/MANUFACTURER
Alere San Diego, San Diego, CA, by letter on March 15, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
These lots have an increased frequency of Troponin I results >0.05ng/mL for samples which are found to be below 0.05ng/mL upon additional testing.
VOLUME OF PRODUCT IN COMMERCE
1,284 kits
DISTRIBUTION
Nationwide, Brazil, China, India and Kuwait
___________________________________
PRODUCT
Siemens Axiom Sensis XP diagnostic programmable computer Diagnostic programmable computer. Model number 10608285. Recall # Z-1506-2012
CODE
Serial numbers: 41021, 10006, and 6045
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated February 22, 2012.
Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON                                                                                                                                                
There is a potential malfunction in the connection of a Sensis EP system with Carto(R) 3 dedicated cable set (part number 14411343) with the Carto 3 system from Bionsense Webster.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles, conjugate and assay diluent; ARCHITECT STAT Troponin-I is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events. Recall # Z-1509-2012
CODE
Lot number 74264UN11, expiration date 31OCT12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letter dated April 11, 2012.
Manufacturer: Fisher Diagnostics, A Company of Fisher Scientific LLC, Middletown, VA. Firm initiated recall is ongoing.
REASON                                                                                                                                                
The lot of Troponin-I is demonstrating a shift in expected results in some cases, and varies from kit to kit. A concentration change of up to +/-55% could occur when switching kits without recalibrating.
VOLUME OF PRODUCT IN COMMERCE
8,713 kits
DISTRIBUTION
Internationally
___________________________________
PRODUCT
1) Zimmer Dental Trabecular Metal, TMT4B10 IMP TM 4.1MM MTX FULL,10MM; Rx, Sterile R. The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region.(Catalog TMT indicates textured collar). Recall # Z-1510-2012;
 
2) Zimmer Dental Trabecular Metal, TMT4B11 IMP TM 4.1MM MTX FULL,11.5MM; Rx, Sterile R. The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, Page 4 of 6 especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Recall # Z-1511-2012;
 
3) Zimmer Dental Trabecular Metal, TMT4B13 TM 4.1MM MTX FULL,13 MM; Rx, Sterile R. The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. TMT catalog # indicates textured collar. Recall # Z-1512-2012;
 
4) Zimmer Dental Trabecular Metal, TMM4B10 TM 4.1MM MTX FULL,10 MM; Rx, Sterile R. The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Catalog TMM indicates machined collar. Recall # Z-1513-2012;
 
5) Zimmer Dental Trabecular Metal Implant, TMM4B11, 4.1mm x11.5 MM; 3.5 mm implant TM, MTX Rx, Sterile R. The Trabecular Metal Dental Implants are designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Catalog TMM indicates machined collar. Recall # Z-1514-2012;
 
6) Zimmer Dental Trabecular Metal Implant, TMM4B13, 4.1mm x13MM; 3.5 mm implant TM, MTX Rx, Sterile R. The Trabecular Metal Dental Implant is designed to replace one or more missing teeth in the maxilla or mandible and is used during immediate loading or for loading after a conventional healing period. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load (i.e. the contacting surfaces of opposing teeth, especially the biting or chewing surfaces). The 4.1mmD Trabecular Metal Implants are intended to be splinted to additional implants when used in the posterior region. Recall # Z-1515-2012
CODE
1) Lot: Lot 61840378, 61960160, 61967093, 61982587;
2) Lot: 61926103, 61960168, 61967139, 61978064, 61989032;
3) Lot: 61926106, 61960169, 61967140, 61973165, 61985653;
4) Lot: 6197019, 61971479, 61960143, 6180365, 6184063;
5) Lot: 61926101, 61926107, 61960149, 619267162, 61992706;
6) Lot: 61926104, 61960158, 61967141, 61973167
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by letter dated April 24, 2012.
Manufacturer: Zimmer Dental Inc., Carlsbad, CA. Firm initiated recall is ongoing.
REASON                                                                                                                                                
This Zimmer Dental voluntary device recall resulted from an investigation into the February 2012 complaint involving an apical tip of a 4.1mm D Trabecular Metal Implant which separated from the implant assembly during surgery on a patient with a dense (Type D1), thick, inferior border. The recall correction includes adding precautions to the Instructions for Use regarding the placement of a 4.1mm D Trabecular Metal implant in mandibles with dense(Type D1), thick, inferior border, which will provide a wider apical osteotomy to ensure that the apical tip of the implant is not subjected to excessive torque during the final seating process.
VOLUME OF PRODUCT IN COMMERCE
1,209 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM) NT - proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT0proBNP) in heparinized plasma. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patient with acute coronary syndrome and heart failure. Recall # Z-1516-2012
CODE
 Lot numbers 211214002, exp 04/28/2012; 211227002, exp 05/11/2012; 211283002, 07/06/2012; 211297002, 07/20/2012; 211339002, 08/31/2012; 212003002, exp 09/29/2012; and 212023002, exp 10/19/2012
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated March, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Firm has confirmed a low frequency of calibration failures due to slope errors that are not resolved with routine maintenance with the specific SCS Pro-BNP lots listed. This issue only causes the slope error failures but does not affect patient results when the calibration is within specifications.
VOLUME OF PRODUCT IN COMMERCE
1,899 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) 8" x 4" 16-ply X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Made in China; item IMSGZX8416-10 For use to control bleeding and absorb fluid. Recall # Z-1517-2012;
 
2) 8" x 4" 16-ply Dual X-Ray Gauze, hospital fold, banded in 10's; 200 pieces per bag, 10 bags per case; Made in China; item IMSGZXX8416-10 For use to control bleeding and absorb fluid. Recall # Z-1518-2012
CODE
1) Lot numbers: 11-6362-1, 11-6465-1, 11-6559-1;
2) Lot number 11-6559-1
RECALLING FIRM/MANUFACTURER
Recalling Firm: International Medsurg Connection, Inc., Schaumburg, IL, by telephone, e-mail and/or fax on April 9, 2012. 
Manufacturers: Jiangsu Likang Group Corp., Wujiang City, Jiangsu, China;
Winer Industries (Shenzhen) Co., Ltd., Shenzhen, China;   
Shaoxing Zhengde Surgical Dressing Co., Ltd., Shaoxing, Zhejiang Prov., China.
Firm initiated recall is ongoing
REASON                                                                                                                                                
The lots of X-Ray Gauze are contaminated with foreign material, including remnants of cotton seeds and lint.
VOLUME OF PRODUCT IN COMMERCE
291 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Instrumentation Laboratory (IL) HemosiL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems. Recall # Z-1519-2012
CODE
Lot Numbers: B01424 Exp Date: March 31, 2012; B11498 Exp Date: July, 31, 2012; B11655 Exp Date: November 30, 2012; B11687 Exp Date: January 31, 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Instrumentation Laboratory Co., Bedford, MA, by e-mail on March 29, 2012 and by letter on April 11, 2012.
Manufacturer: Biokit Sa, Llica d'Amunt, Spain. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay.
VOLUME OF PRODUCT IN COMMERCE
9,320 kits
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
1) Terumo Custom Cardiovascular Procedure Kit (manufactured to the design and specifications of the purchaser/user) for the application it is intended by the user. X-COATED CHANGE OUT PACK WITH FX15E Product Code: 74257. Recall # Z-1523-2012;
 
2) Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. FX15RE40 PACK Product Code:66024. Recall # Z-1524-2012;
 
3) Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended FX15RE40 PACK Product Code:66031. Recall # Z-1525-2012;
 
4) Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED FX15RE40 PACK Product Code: 73484. Recall # Z-1526-2012;
 
5) Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED FX15 ADULT PACK Product Code: 73399. Recall # Z-1527-2012;
 
6) Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. Cardiovascular Custom Procedure Kit Adult Product Code: 71060-01. Recall #Z-1528-2012;
 
7) Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED PEDIATRIC 1/4X3/8 RX15 PACK Product Code: 72225-01. Recall # Z-1529-2012;
 
8) Terumo Custom Cardiovascular Procedure Kit-PEDIATRIC PACK Product Code: 71062-01 Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Recall # Z-1530-2012;
 
9) Terumo Custom Cardiovascular Procedure Kit-: CUSTOM X-COATED LOW PRIME Product Code: 72015-03 Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Recall # Z-1531-2012;
 
10) Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 Product Code: 72015-04 Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Recall # Z-1532-2012;
 
11) Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 x1/2 pack Product Code: 72015-05 Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Recall # Z-1533-2012;
 
12) Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RW30 Product Code: 73679 Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Recall # Z-1534-2012
 
13) Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RE40 Product Code: 73673 Manufactured to the design and specifications of the purchaser/user) for the application it is intended. Recall # Z-1535-2012
CODE
1) Lot No.:PA30;
2) Lot Nos: NE11; NE11T; NH05; NH11; NK08; NM17; NP12; PA16; PC06;
3) Lot Nos: NH05; NH11; NM10; NP12; PA02; PC27;
4) Lot No: MG01;
5) Lot No: MH06;
6) Lot No: MH12; MK23; MP20; NC21; NK22;
7) Lot No: NA10; ND21; NG27; NH11;
8) Lot No: MD29; ME26; MK02; NA17; NC14; NH05; NL12; NN28; PA09;
9) Lot No: MD08; ME05; MF17; MH26; MK16; ML07;
10) Lot No: MN29; MP13; ND28;
11) Lot No: NF09; NG20; NG20R; NH11; NH11R;
12) Lot No: NA17
13) Lot No: NA17
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ashland, MA, by letter on April 12, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Loose connections (i.e., connections between PVC circuit tubing and Oxygenator ports) may result in leaks and patient blood loss.
VOLUME OF PRODUCT IN COMMERCE
1,022 units
DISTRIBUTION
AL, AZ, CA, MO, NY and Canada
___________________________________
PRODUCT
HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch label***HAEMACURE***HemaSyst***tm***Contents: One ***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604*** CE 0297*** 2014/10***40680b/20004-02***CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a licensed physician (or properly licensed practitioner).***Contents of unopened undamaged package are sterile***CE 0297*** Box label***Contents: 5 packages of 1 each***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" (10.2 cm)***REF H-1604***CE 0297***STERILE EO*** 2014/10***40681B/20544***". Sterile, single-use instrument for the application of two liquids. Recall # Z-1537-2012
CODE
Lot Number: 111144, expiration 10/2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: Haemacure Corp., Sarasota, FL, by letters via e-mail on November 16, 2009.
Manufacturer: Micromedics, Inc., Eagan, MN. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
This product has been recalled due to the lot number being different on the box and pouch. The lot number on the box label was incorrectly printed as 11144 instead of 111144. The pouch label referenced the correct lot number, 111144.
VOLUME OF PRODUCT IN COMMERCE
7 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; a) component catalog #12833, b) kit catalog #303-305. The TheraTest EL-RF/3 is intended as an aid to the diagnosis of Rheumatoid Arthritis (RA). Recall # Z-1546-2012
CODE
a) Lot number 11118586, exp. 28 DEC 2012; b) lot number 11118583, exp. 28 NOV 2012
RECALLING FIRM/MANUFACTURER
Thera Test Laboratories, Inc., Lombard, IL, by letters dated March 28, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
The RF IgA Calibrator component of the EL-RF/3 Rheumatoid Factor test system may be unstable, resulting in a drop in the RF IgA calibrator OD value which could invalidate an RF IgA test run.
VOLUME OF PRODUCT IN COMMERCE
207 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Patient Specific Instruments LPS-Flex Pin Guides (Femur and Tibia) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID--0242-LF; REF 005970-000-02. Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans. Recall # Z-1543-2012;
 
2)Patient Specific Instruments N-K Flex PIN Guides (Femur and Tibia) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID - 0864-R3; REF 005970-000-03. Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans. Recall # Z-1544-2012
CODE
1) Lot 56529819, Exp 2012-09-06;
2) Lot 56529886, Exp 2012-09-08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Materialise Dental, Leuven, Belgium, by telephone on March 23, 2012.
Manufacturer: Materialise USA LLC, Plymouth, MI. Firm initiated recall is complete.
REASON
A field representative reported patient specific --0242 L tibia guide case packaging contained a different patient specific -0864-R tibia guide. The two patient specific products had been switched in packaging. Neither product had been delivered to the end user.
VOLUME OF PRODUCT IN COMMERCE
1 for each patient
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied clean and not sterile. All implants and instruments should be cleaned and sterilized prior to surgery. AORN recommended practices for in hospital sterilization should be followed. Sterilization testing of components has shown the following recommendations for sterilization are effective Method: Steam***Cycle: Pre vacuum***Temperature 270 F (132 C)***Exposure Time: 3 minutes*** Captiva Spine***". Intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Recall # Z-1545-2012
CODE
Serial Number: 002, 004, 007, 009, 011, 015, 017, 018, 019, 020, 024, 025, 035 and 030.
RECALLING FIRM/MANUFACTURER
Captiva Spine, Inc., Jupiter, FL, by letter dated March 23, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Captiva Spine has initiated a correction of the SmartLOX Instructions for Use (IFU) for SmartLOX Cervical Plate System. The pre vacuum sterilization cycle [270 (132 C) for 3 minutes] has not been validated.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters) Cat. No. 13-2251-0. NaturaLyte liquid acid concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates. Recall # Z-1612-2012
CODE
Lot 11PTAC022. Expiration Date: 11/30/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, by letter dated March 28, 2012. 
Manufacturer: Fresenius Medical Care North America, Irving, TX. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Sodium content does not meet product requirements.
VOLUME OF PRODUCT IN COMMERCE
154 drums (55Gal/drum)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant. Recall # Z-1614-2012
CODE
Lot numbers: (2mL) HA100143, HA091236. (4mL) HA090950, HA090944, HA090843, HA090749, HA090947. (8mL) HA100132, HA100142
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Services L.P., Deerfield, IL, by letter dated July 27, 2011.
Manufacturer: Baxter Healthcare Corp., Hayward, CA. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shelf life to expiration) during a Coseal stability study. The parameter that is out specification is an indicator of possible failure for the product to gel appropriately. Coseal's failure to gel does not represent risk for the patient's life. All other stability requirements were met.
VOLUME OF PRODUCT IN COMMERCE
11,160 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ACUSON S1000 ultrasound systems running software version 1.0. The product is indicated for use as an ultrasound imaging system. Recall # Z-1616-2012
CODE
Serial numbers: 205730 205732 205523 205557 205721 205704 205747 205709 205685 205796 205751 205797 205771 205786 205795 205775 205785 205773 205783 205782 205791 205793 205789 205804 205873 205848 205821 205811 205840 205708 205909 206029 206072 205814 205977 205935 205971 206089 206120 205988 206112 206038 206087 205956 205937
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on April 25, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
When using the Advanced SieClear spatial compounding feature a synchronization error may occur which can cause a mismatch between the image and the depth scale.
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
TrueBeam and TrueBeam STx V1.0, 1.5, 1.6.95 and below. Model number H19; TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy anywhere in the body where radiation treatment is indicated. Recall # Z-1617-2012.
CODE
Serial numbers: H191001 H191061 H191121 H191180 H191002 H191063 H191122 H191181 H191003 H191064 H191123 H191182 H191005 H191065 H191124 H191183 H191006 H191066 H191125 H191184 H191007 H191067 H191126 H191185 H191008 H191068 H191127 H191186 H191009 H191069 H191128 H191187 H191010 H191070 H191129 H191188 H191011 H191071 H191130 H191189 H191012 H191072 H191131 H191190 H191013 H191073 H191132 H191191 H191014 H191074 H191133 H191192 H191015 H191076 H191134 H191194 H191016 H191077 H191135 H191195 H191017 H191078 H191136 H191197 H191018 H191079 H191137 H191198 H191019 H191080 H191138 H191199 H191020 H191081 H191139 H191201 H191021 H191082 H191140 H191202 H191022 H191083 H191141 H191203 H191023 H191084 H191142 H191205 H191024 H191085 H191143 H191206 H191025 H191086 H191144 H191207 H191026 H191087 H191145 H191209 H191027 H191088 H191146 H191210 H191028 H191089 H191147 H191213 H191029 H191090 H191148 H191215 H191030 H191091 H191149 H191221 H191031 H191092 H191150 H191225 H191032 H191093 H191151 H191226 H191033 H191094 H191152 H191227 H191034 H191095 H191153 H191228 H191035 H191096 H191154 H191036 H191097 H191155 H191037 H191098 H191156 H191038 H191099 H191157 H191039 H191100 H191158 H191040 H191101 H191159 H191041 H191102 H191160 H191042 H191103 H191161 H191043 H191104 H191162 H191044 H191105 H191163 H191045 H191106 H191164 H191046 H191107 H191165 H191047 H191108 H191166 H191048 H191109 H191167 H191049 H191110 H191168 H191051 H191111 H191169 H191052 H191112 H191170 H191053 H191113 H191171 H191054 H191114 H191172 H191055 H191115 H191174 H191056 H191116 H191175 H191057 H191117 H191176 H191058 H191118 H191177 H191059 H191119 H191178 H191060 H191120 H191179
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Oncology Systems, Palo Alto, CA, by letter on April 9, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Varian received a report involving a Gantry collision and is sending a notification to remind users of the collision protection tools available with TrueBeam and TrueBeam STx, including actions the operator should be aware of.
VOLUME OF PRODUCT IN COMMERCE
207 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Cutting Edge Acetabular Spherical Reamer 44 M. The CuttingEdge acetabular reamers are used to ream the acetabulum and prepare the bone for the insertion of the shell during hip arthroplasty. Surgical procedures for shells used with CuttingEdge instruments indicate that reaming should begin with a Spherical Reamer that is 4mm smaller than the templated or gauged size of the planned shell. Per the procedures, reaming should increase in size by 1mm increments until final sizing is achieved. Surgical judgment is used to assess bone stock, bone quality, desired level of press fit, and proper amount of reaming. Catalog Number 2102-0444 No 510 K number. Recall # Z-1618-2012
CODE
Lot number V2010068, No expiration date
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated December 29, 2011. Firm initiated recall is ongoing.
REASON
A 46mm acetabular reamer was lasermarked as a 44m reamer and distributed to the field.
VOLUME OF PRODUCT IN COMMERCE
134 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) A translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane, Qty 1 Sterile Rx only 15mm X 20mm, Part Number 20650-01. Qty 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30�C (86�F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. Recall # Z-1621-2012;
 
2) A translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane, Qty 1 Sterile Rx only 20mm X 30mm REF 20650-02 6280-02 Rev.AE Qty 1 STERILE EO Sterilized using ethylene oxide Do not store product above 30�C (86�F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. Recall # Z-1622-2012;
 
3)A translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla Guide Collagen Membrane, Qty 1 Sterile Rx only 30mm X 40mm REF 20650-03 6280-03 Rev.AE Qty 1 Sterile EO Sterilized using ethylene oxide Do not store product above 30�C (86�F) Do not re-use. CollaGuide Collagen Dental Membrane is indicated for simultaneous use of guided bone regeneration (GBR)-membrane and implants, augmentation around implants placed in immediate extraction sites, augmentation around implants placed in delayed extraction sockets, localized ridge augmentation for later implantation, alveolar ridge reconstruction for prosthetic treatment, filling of bone defects after root resection, cystectomy, removal of retained teeth, guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects. Recall # Z-1623-2012
CODE
1) Lot # 88519 Expiration date 03/31/12 Lot # 92008 Expiration date 09/30/12 Lot # 92067 Expiration date 09/30/12 Lot # 92338 Expiration date 10/31/12 Lot # 94764 Expiration date 03/31/13 Lot # 95275 Expiration date 05/31/13 Lot # 95910 Expiration date 05/31/13 Lot # 97039 Expiration date 08/31/13 Lot # 98318 Expiration date 11/30/13 Lot # 98343 Expiration date 12/31/13 Lot # 84504 Expired Lot # 85270 Expired Lot # 88165 Expired;
 
2) Lot # 91025 Expiration date 07/31/12 Lot # 92339 Expiration date 10/31/12 Lot # 94765 Expiration date 03/31/13 Lot # 95276 Expiration date 05/31/13 Lot # 95911 Expiration date 05/31/13 Lot # 97040 Expiration date 08/31/13 Lot # 98319 Expiration date 11/30/13 Lot # 84505 Expired Lot # 85271 Expired Lot # 89495 Expired Lot # 89542 Expired;
 
3) Lot # 91026 Expiration date 07/31/12 Lot # 92340 Expiration date 10/31/12 Lot # 94766 Expiration date 03/31/13 Lot # 95912 Expiration date 05/31/13 Lot # 97041 Expiration date 08/31/13 Lot # 98321 Expiration date 11/30/13 Lot # 84506 Expired Lot # 86568 Expired Lot # 89496 Expired.
RECALLING FIRM/MANUFACTURER
Kensey Nash Corp., Exton, PA, by letter dated March 12, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
Recall has been initiated due to concerns regarding the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
6,387 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Pelleve Non-Ablative Wrinkle Treatment Handpiece Pelleve---Elegance through science---Contents: One (1) Pelleve Handpiece (Reusable) --- Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV. Recall # Z-1624-2012
CODE
All lots of the Pelleve reuseable handpieces manufactured to date are subject to this recall.
RECALLING FIRM/MANUFACTURER
Ellman International, Inc., Oceanside, NY, by letter beginning May 4, 2012. Firm Initiated recall is ongoing.
REASON                                                                                                                                                
Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure, sparking, and fire.
VOLUME OF PRODUCT IN COMMERCE
1,088 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
8F Plastic Dignity Mid-Sized CT Port w/Silicone Filled Suture Holes and w/Attachable ChronoFlex Polyurethane Catheter. Catalog # MRCTI8000S. The Power Injectable, Implantable Infusion Port is an implantable single fluid reservoir port with a polyurethane (8F) catheter attachable for application by the inserting physician. Recall # Z-1626-2012
CODE
Lot #MDPZ600, Expiration date 2015/02
RECALLING FIRM/MANUFACTURER
Medical Components, Inc dba MedComp, Harleysville, PA, by e-mail and letter on April 12, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
50 trays of Dignity Low Profile CT Port were labeled as Dignity Mid-Sized CT Port.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
Nationwide and Spain
___________________________________
PRODUCT
Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. Intended for use in providing direct tracheal access for airway management. Recall # Z-1628-2012
CODE
Lot: 01107055 (73 units) and Lot: 01103307 (50 units)
RECALLING FIRM/MANUFACTURER
Arcadia Medical Corp., Crown Point, IN, by letter dated April 18, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
A defect in 3 tracheostomy tubes. The defect observed was a separation in the bond between the proximal junction of the neck flange and the cannula.
VOLUME OF PRODUCT IN COMMERCE
123 units
DISTRIBUTION
Nationwide, UK and France
___________________________________
PRODUCT
Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The system does not expose the patient to any ionizing radiation. The MRI Subsystem produces cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structures of the whole body. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient’s body (specific pharmaceuticals are used for whole body, brain, and other organ imaging). The PET and MRI portion of the system can be used either as an integrated system or as a stand-alone MRI or PET system. The MRI subsystem provides data suitable for use in attenuation correction of the PET acquired data. Recall # Z-1646-2012
CODE
Serial Numbers 11004-11014 are subject to recall/software correction.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated April 13, 2012. Firm initiated recall is ongoing.
REASON
Software errors. A number of non-conformances were identified and corrected by Philips Medical for their Ingenuity TF PET/MRI Systems running software version 3.7.1. The firm states that these non-conformances stemmed from software and/or documentation errors, and that software corrections are being performed in order to 'improve the overall quality and functionality of the Ingenuity TF CT/MRI Systems running version 3.7.1 software'.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Nationwide, China, Finland, Germany, South Korea, Spain, and Switzerland
___________________________________
PRODUCT
EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation. Recall # Z-1647-2012
CODE
Lot Number: 13140790A
RECALLING FIRM/MANUFACTURER
Biosense Webster, Inc., Irwindale, CA, by letter dated December 17, 2007. Firm initiated recall is complete.
REASON                                                                                                                                                 
The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs. Recall # Z-1650-2012
CODE
Lot/ Serial Number (USA)TE012171, TE012151, TE012142, TE012159, TE012158, TE012154, TE012186, TE012185, TE012161, TE012139, (UK)TE012182
RECALLING FIRM/MANUFACTURER
College Park Industries, Inc., Fraser, MI, by telephone on April 5, 2012 and by letter dated April 24, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
An incorrect shorter part (pyramid) was installed in the foot. A foot of this size and configuration requires a longer pyramid. Customers requiring the extra firm configuration may have a minimal risk of component failure, which could be implicated in a potential fall.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide and England
___________________________________
PRODUCT
MLCi/MCLi2. Radiation therapy. Recall # Z-1651-2012
CODE
MRT 2424/MRT 14401
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated April 2012.
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, United Kingdom. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
The Y2 diaphragm block was found loose.
VOLUME OF PRODUCT IN COMMERCE
386 units
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F. Intended to be used in conjunction with guide catheters to access discrete regions of the coronary and or peripheral vasculature and too facilitate placement and exchange of guidewired and other interventional devices. Recall #Z-1655-2012
CODE
Unit: 555038
RECALLING FIRM/MANUFACTURER
Vascular Solutions, Inc., Minneapolis, MN, by letter dated January 17, 2012. Firm initiated recall is complete.
REASON
Use of this product could result in the catheter shaft separating from the pushwire on the device. This may cause a procedural delay and/or injury possibly requiring medical intervention.
VOLUME OF PRODUCT IN COMMERCE
330 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Product is labeled in part: "***is immunosimplicity***HSV 1&2 IgM***Enzyme Immunoassay Test Kit***For the Detection of HSV 1&2 IgM antibodies***Catalog No: 720-350***Exp. Date: ***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: ***For In Vitro Diagnostic Use***Caution, consult accompanying documents. *** Biohazard***" The Is-HSV 1&2 IgM test kits are packaged in cardboard boxes with individual components secured within a foam insert. The Diamedix Is-HSV 1&2 IgM Test Kit is intended for the qualitative detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 in human serum by indirect enzyme immunoassay. This test can aid in the diagnosis of a primary or reactived infection with HSV. The performance of this assay has not been established for use in neonates, infants, or on cord blood, and immunocompromised patients. Recall # Z-1520-2012
CODE
Lot # 60701, Exp. June 30, 2012
RECALLING FIRM/MANUFACTURER
Diamedix Corp., Miami, FL, by letters dated January 16, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                
The Positive Control for this lot is Out of Specification.
VOLUME OF PRODUCT IN COMMERCE
442 Test Kits
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile, Incorrect Picture Label, Trochanter Plate (50-60 mm) Mallory/Head The Ultra-DriveTM System is used to aid in the removal of bone cement (PMMA) and noncemented implants in conjunction with revision arthroplasty. The Ultra-Drive" device converts standard electrical energy into mechanical energy, via an ultrasonic transducer in the Ultra-Drive" handpiece. This energy is transmitted through individually tuned tool tips in acoustic waves. causing the tool tip to vibrate at a controlled high speed. This action breaks down bone cement and cuts through cancellous bone. Recall # Z-1521-2012
CODE
Lot number: 409680
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN., by letter dated April 18, 2012. Firm initiated recall is ongoing.
REASON                                                                                                                                                 
Incorrect product picture label was on the product box.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Nationwide, Europe, Australia
___________________________________
PRODUCT
QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. Recall # Z-1615-2012
CODE
Serial Numbers: liqc.018778, liqc.020447, liqc.020428, liqc.024472, liqc.027039, liqc.024195, liqc.026718, liqc.023495, liqc.027065, liqc.024252, liqc.018722, liqc.024377, liqc.019808, liqc.017029, liqc.017310, liqc.026701, liqc.024190, liqc.019075, liqc.027351, liqc.023253, liqc.019497, liqc.019215, liqc.019217, liqc.017965, liqc.020530, liqc.024293, liqc.021530, liqc.026353, liqc.017900, liqc.019915, liqc.018447, liqc.021086, liqc.027072, liqc.023241, liqc.018169, liqc.017876, liqc.022049, liqc.026409, liqc.018126, liqc.019519, liqc.017579, liqc.018271, liqc.017531, liqc.017532, liqc.018255, liqc.023888, liqc.023340, liqc.023343, liqc.023342, liqc.018534, liqc.018536, liqc.018256, liqc.017532, liqc.019582, liqc.021064, liqc.020981, liqc.021944, liqc.021764, liqc.021284, liqc.017741, liqc.017738, liqc.024298, liqc.026760, liqc.027063, liqc.022321, liqc.022320, liqc.020843, liqc.022009, liqc.026620, liqc.026643, liqc.026456, liqc.021428, liqc.021402, liqc.022054, liqc.019577, liqc.023782, liqc.023710, liqc.023708, liqc.019360, liqc.017682, liqc.021670, liqc.022983 (UK), liqc.022846 (UK)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Intel-GE Care Innovations LLC, Roseville, CA, by telephone or email on July 30, 2011 and letters on August 12, 2011. 
Manufacturer: RDI, Inc., Mount Kisco, NY. Firm initiated recall is complete.
REASON                                                                                                                                                 
The QuietCare production system experienced a partial outage on 7/29/11. As a result of the partial outage, some monitoring data about residents' movements was not processed in the production system, and alerts were therefore not sent to caregivers. The problem was identified and corrected and the unprocessed data was recovered and processed. However, because of the time lag in processing, a feature of the system that disables duplicate delivery of old alerts prevented a few alerts from being generated. The raw data was then analyzed further and caregivers were contacted to determine the impact of potential missed alerts.
VOLUME OF PRODUCT IN COMMERCE
82 units
DISTRIBUTION
Nationwide and United Kingdom
 
END OF ENFORCEMENT REPORT FOR MAY 30, 2012
 
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