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U.S. Department of Health and Human Services

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Enforcement Report for April 22, 2009

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

 

April 22, 2009
09-16

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I 
___________________________________ 
PRODUCT 
Hershey Creamery's Peanut Butter Pretzel Explosion Ice Cream 3 gallon bulk can package (red in color) labeled with product information UPC number 2468205381, Recall # F-189-9
CODE 
Lot number: 8135
RECALLING FIRM/MANUFACTURER 
Hershey Creamery Co., Harrisburg ,  PA , by telephone on February 25, 2009. Firm initiated recall is complete.
REASON 
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella. 
VOLUME OF PRODUCT IN COMMERCE 
42 units
DISTRIBUTION 
CT, FL, KY, MA, MD, MI, NC, OH, PA, and RI
___________________________________ 
PRODUCT 
a) Euphoria Chocolate Company Milk Chocolate Peanut Cluster, 2 oz cluster packaged in plastic with 24 peanut clusters per case. UPC code 0 50469 04175 5. Product may be purchased by the case or by individual cluster, Recall # F-190-9;
 
b) Euphoria Chocolate Company Dark Chocolate Peanut Cluster, 2 oz cluster packaged in plastic with 24 peanut clusters per case. UPC Code 0 50469 04172 4. Product may be purchased by the case or by individual cluster, Recall # F-191-9
CODE 
Best if used by date of 2 12 09 and prior. (In month, date, year format)
RECALLING FIRM/MANUFACTURER 
Euphoria Chocolate, Co., Eugene , OR , by telephone on February 12, 2009 and March 5, 2009 and by press release on March 13, 2009. Firm initiated recall is ongoing.
REASON 
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella. 
VOLUME OF PRODUCT IN COMMERCE 
95.5 cases (2,292 clusters)
DISTRIBUTION 
OR
___________________________________ 
PRODUCT 
Brighton Beach Chocolate Candy, no weight on label. Each candy is individually foil-wrapped (blue, turquoise and yellow in color) and was distributed in 10 lb. boxes. Ingredients: dry apricots (SO2), dark chocolate (sugar, chocolate liquor, chocolate liquor processed with alkali, cocoa butter, butteroil, soy lecithin added as an emulsifier and vanilla) sulfure dioxide as a preservative to promote color retention. The candy is not suppose to contain walnuts according to the manufacturer, Recall # F-192-9
CODE 
Not coded
RECALLING FIRM/MANUFACTURER 
Golden Chocolate International, Inc., Brooklyn , NY , by press release on March 13, 2009 and by letters dated March 13, 2009. Firm initiated recall is ongoing.
REASON 
The Brighton Beach chocolate candy contains undeclared walnuts. This was confirmed by FDA analysis.
VOLUME OF PRODUCT IN COMMERCE 
Unknown
DISTRIBUTION 
NY, MA, PA, MD, MI, OH, CA and Canada
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II 
___________________________________ 
PRODUCT 
Archway Iced Oatmeal Crispy Snacking Cookies, Net wt. 14 oz. Bag, Recall # F-188-9
CODE 
Best By: JUN 13 09, JUN 21 09, JUN 29 09
RECALLING FIRM/MANUFACTURER 
Archway & Mothers Cookie Co., Ashland ,  OH , by e-mail on February 8, 2009. Firm initiated recall is ongoing.
REASON 
The product contains a small amount of fish gelatin in the icing portion of the cookie and this ingredient is not declared in the ingredient listing.
VOLUME OF PRODUCT IN COMMERCE 
560 cases
DISTRIBUTION 
NJ, NY, MI, PA
  
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0669-09
CODE 
Unit: 72H114582 (split unit)
RECALLING FIRM/MANUFACTURER 
LifeSouth Community Blood Centers, Inc. – Birmingham Region, Birmingham , AL , by facsimile on July 11, 2008. Firm initiated recall is complete.
REASON 
Platelets, inappropriately prepared by splitting the product into two storage bags instead of one, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0670-09
CODE 
Unit: 72J10388X
RECALLING FIRM/MANUFACTURER 
LifeSouth Community Blood Centers, Inc. – Birmingham Region, Birmingham , AL , by facsimile on December 12, 2008. Firm initiated recall is complete.
REASON 
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0709-09
CODE 
Unit: 72J255339
RECALLING FIRM/MANUFACTURER 
LifeSouth Community Blood Centers, Inc. – Birmingham Region, Birmingham , AL , by facsimile on December 29, 2008. Firm initiated recall is complete.
REASON 
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0710-09
CODE 
Unit: 72H502185
RECALLING FIRM/MANUFACTURER 
Recalling Firm: LifeSouth Community Blood Centers – Wiregrass Region, Dothan , AL , by facsimile on September 3, 2008.
Manufacturer: LifeSouth Community Blood Centers – Montgomery Region, Montgomery , AL. Firm initiated recall is complete.
REASON 
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Source Plasma, Recall # B-0727-09
CODE 
Units: 4190063060, 4190062674, 4190061124, 4190060580, 4190060146, 4190059626, 4190059286, 4190058781, 4190058316, 4190057814, 4190057361, 4190056903, 4190056269, 4190055967, 4190055415, 4190055087, 4190054554, 4190054240, 4190053695, 4190053367, 4190052823, 4190052521, 4190051989, 4190051702, 4190051179, 4190050879, 4190050338, 4190050033, 4190049471, 4190049150, 4190048617, 4190048330, 4190047811, 4190047515, and 4190046946
RECALLING FIRM/MANUFACTURER 
ZLB BioServices, Inc., dba ZLB Plasma Services, Fort Worth , TX , by facsimile on November 7, 2006. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor who did not have a complete annual physical exam, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
35 units
DISTRIBUTION 
IL
___________________________________ 
PRODUCT 
Red Blood Cells, Leukocytes Reduced, Recall # B-0728-09
CODE 
Units: 13FR85910 and 13FV65622
RECALLING FIRM/MANUFACTURER 
American Red Cross, Southeastern Michigan Region, Detroit, MI, by electronic notification and telephone on April 3, 2007 and letter on April 25, 2007 and May 25, 2007. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
MI
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0734-09
CODE 
Unit: W071208008314
RECALLING FIRM/MANUFACTURER 
Medic, Inc., Knoxville , TN , by telephone on June 4, 2008 and by follow-up letter dated June 6, 2008. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor who received an oral piercing within 12 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
TN
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0745-09
CODE 
Unit: 72H633124
RECALLING FIRM/MANUFACTURER 
LifeSouth Community Blood Centers, Inc., Huntsville , AL , by fax on September 16, 2008. Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0746-09
CODE 
Unit: 72H78234X
RECALLING FIRM/MANUFACTURER 
Recalling Firm: LifeSouth Community Blood Centers – Montgomery Region, Montgomery , AL , by facsimile on September 3, 2008.
Manufacturer: LifeSouth Community Blood Centers – Wiregrass Region, Dothan , AL . Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0747-09
CODE 
Unit: 72H747963
RECALLING FIRM/MANUFACTURER 
Recalling Firm: LifeSouth Community Blood Centers – Montgomery Region, Montgomery , AL , by fax on October 17, 2008.
Manufacturer: LifeSouth Community Blood Centers Inc., – East Alabama Region, Opelika , AL . Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0748-09
CODE 
Unit: 9080619
RECALLING FIRM/MANUFACTURER 
The Blood Connection, Inc., Piedmont , SC , by telephone and by letter dated August 13, 2008. Firm initiated recall is complete.
REASON 
Blood product, which was labeled as leukoreduced, but was not tested to verify white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
SC
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0750-09
CODE 
Unit: 72H931361
RECALLING FIRM/MANUFACTURER 
LifeSouth Community Blood Centers , Mobile , AL , by fax on October 2, 2008. Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0751-09
CODE 
Unit: 72H641068
RECALLING FIRM/MANUFACTURER 
Recalling Firm: LifeSouth Community Blood Centers , Mobile , AL , by fax on October 10, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inc., Gainesville , FL. Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0754-09
CODE 
Unit: 72H746850
RECALLING FIRM/MANUFACTURER 
Recalling Firm: LifeSouth Community Blood Centers , Mobile , AL , by fax on September 29, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inc., Gainesville , FL. Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0755-09
CODE 
Unit: 72H747742
RECALLING FIRM/MANUFACTURER 
Recalling Firm: LifeSouth Community Blood Centers – Montgomery Region, Montgomery , AL , by fax on September 4, 2008.
Manufacturer: LifeSouth Community Blood Centers Inc., – East Alabama Region, Opelika , AL . Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0756-09
CODE 
Unit: 72H502879
RECALLING FIRM/MANUFACTURER 
Recalling Firm: LifeSouth Community Blood Centers, Inc., Huntsville , AL , by fax on October 18, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inc., Morgan Region, Decatur, AL. Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0757-09
CODE 
Unit: 72H938522
RECALLING FIRM/MANUFACTURER 
LifeSouth Community Blood Centers, Inc., Huntsville , AL , by fax on October 18, 2008. Firm initiated recall is complete.
REASON 
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0758-09
CODE 
Unit: F14335
RECALLING FIRM/MANUFACTURER 
Michigan Community Blood Centers , Grand Rapids , MI , by fax on August 29, 2008. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor who reported residence in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
MI
___________________________________ 
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0759-09;
b) Platelets, Recall # B-0760-09
CODE 
a) and b) Unit: F55287
RECALLING FIRM/MANUFACTURER 
Michigan Community Blood Centers , Grand Rapids , MI , by fax on August 11, 2008. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
MI
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________ 
PRODUCT 
Recovered Plasma, Recall # B-0729-09
CODE 
Units: 13FR85910 and 13FV65622
RECALLING FIRM/MANUFACTURER 
American Red Cross, Southeastern Michigan Region, Detroit, MI, by electronic notification and telephone on April 3, 2007 and letter on April 25, 2007 and May 25, 2007. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
MI
___________________________________ 
PRODUCT 
a) Red Blood Cells, Recall # B-0741-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0742-09
CODE 
a) Unit: 0415136;
b) Units: 0457119; 0457129
RECALLING FIRM/MANUFACTURER 
The Blood Center , New Orleans , LA , by telephone on January 25, 2008 and by follow-up letter dated February 8, 2008. Firm initiated recall is complete.
REASON 
Blood products, without documentation of time out of controlled storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
3 units
DISTRIBUTION 
LA, MS
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0743-09
CODE 
Units: 0423937, 0423935
RECALLING FIRM/MANUFACTURER 
The Blood Center , New Orleans , LA , by telephone on January 14, 2008 and by follow-up letter dated January 16, 2008. Firm initiated recall is complete.
REASON 
Blood products, labeled as Leukocytes Reduced with an extended expiration time, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
LA
___________________________________ 
PRODUCT 
Red Blood Cells, Recall # B-0744-09
CODE 
Unit: 0458019
RECALLING FIRM/MANUFACTURER 
The Blood Center , New Orleans , LA , by telephone and fax on October 16, 2007. Firm initiated recall is complete.
REASON 
Blood product, prepared from a unit of Whole Blood with an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
LA
___________________________________ 
PRODUCT 
Source Plasma, Recall # B-0753-09
CODE 
Unit: 08FINF1457
RECALLING FIRM/MANUFACTURER 
BioLife Plasma Services, L.P, Fort Wayne , IN , by fax on December 11, 2008. 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
  
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I 
___________________________________ 
PRODUCT 
a) 8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters Product Number: IAB-04830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1210-2009;
 
b) 8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle. Z-1211-2009;
 
c) 8 Fr 30cc Ultra 8 IAB, IAB-05830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1212-2009;
 
d) 8 Fr 40cc Ultra 8 IAB, IAB-05840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1213-2009;
 
e) 7.5 Fr 30cc UltraFlex IAB, IAB-06830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle; Recall # Z-1214-2009;
 
f) 7.5 Fr 40cc UltraFlex IAB, IAB-06840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1215-2009;
 
g) 8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1216-2009;
 
h) 8 Fr 40cc FIBEROPTIX IAB, IAB-05840-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1217-2009;
 
i) 7 FR 30CC Rediguard IAB, IAB-S730C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1218-2009;
 
j) 8 FR 40CC Rediguard IAB, IAB-S840C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1219-2009;
 
k) 9 FR 50CC Rediguard IAB, IAB-R950-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1220-2009;
 
l) ARROW 40cc Drive Line Kits, REF IAK-02692, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle., Recall # Z-1221-2009
 
m) ARROW 50cc Drive Line Kits, REF IAK-02693, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, Recall # Z-1222-2009
CODE 
a) Lot /Serial Numbers: MF6079580 MF6100954 MF7033668 MF7086558 MF7086984 MF7097225 MF7097426 MF7118000 MF7118001 MF7128557 and MF8018922;
 
b) Lot/Serial Numbers: MF6090318 MF6111511 MF7065955 MF7076255 MF7086556 MF7097114 MF7097115 MF7097226 MF7097227 MF7097228 MF7097427 MF7097470 MF7097471 MF7107861 MF7107862 MF7118045 MF7118046 MF7128470 MF7128508 MF8018724 MF8018813 MF8018996 MF8124303 MF8124304 MF9014426 MF9014444 MF9014446 and MF9014447;
 
c) Lot/Serial Numbers: MF6122058 MF7065640 MF7076257 MF7076378 MF7097392 MF7118003 MF7118004 MF7118219 MF7128387 MF7128471 MF7128504 MF7128505 MF8018907 MF8018997 MF8030122 MF8039664 MF8039878 MF8040324 MF8040325 MF8040638 MF8050911 MF8061125 MF8061176 MF8061334 MF8061500 MF8061615 MF8071782 MF8072074 MF8082267 MF8082584 MF8092783 MF8092784 MF8093000 MF8093001 MF8103155 MF8103262 MF8103263 MF8124064 MF8124178 MF8124064 MF8124307 and MF8124408;
 
d) Lot/Serial Numbers: MF7065606 MF7076012 MF7076021 MF7086462 MF7086736 MF7107536 MF7107537 MF7107694 MF7107696 MF7118048 MF7118049 MF7118050 MF7118151 MF7118221 MF7118222 MF7128472 MF7128506 MF7128507 MF8018908 MF8019033 MF8019034 MF8019035 MF8019104 MF8029191 MF8029433 MF8029434 MF8039774 MF8040251 MF8040287 MF8050764 MF8050812 MF8050966 MF8061267 MF8061413 MF8071676 MF8071863 MF8082268 MF8082507 MF8093002 MF8103280 MF8103416 MF8103571 MF8113836 MF8113919 MF8113951 and MF8124345;
 
e) Lot/Serial Numbers: MF8039760 MF8039772 MF8040252 MF8040485 MF8040486 MF8040639 MF8050723 MF8050807 MF8050914 MF8061336 MF8061458 MF8061616 MF8061617 MF8071677 MF8071855 MF8082154 MF8082586 MF8092763 MF8093004 MF8103159 MF8103160 MF8103264 MF8103265 MF8103417 MF8124181 MF8124203 MF8124413 and MF8124414;
 
f) Lot/Serial Numbers: MF8029428 MF8029506 MF8029508 MF8030125 MF8030126 MF8039646 MF8039647 MF8039762 MF8039851 MF8040487 MF8040640 MF8050724 MF8061127 MF8061503 MF8071787 MF8072071 MF8082286 MF8082508 MF8093047 MF8103162 MF8103418 MF8103642 MF8113920 MF8114010 MF8124162 and MF8124162;
 
g) Lot/Serial Numbers: MF6090321 MF6122057 MF7044419 MF7076250 MF7086674 MF7107863 MF7118002 MF7128359 MF7128561 MF8018727 MF8018849 MF8019095 MF8039848 MF8039849 MF8039991 MF8040484 MF8050805 MF8050981 MF8061206 MF8061268 MF8061335 MF8061416 MF8072073 MF8082285 MF8082394 MF8082505 MF8082506 MF8092785 MF8092999 MF8103156 MF8113922 MF8114009 MF8124160 MF8124308 and MF8124409;
 
h) Lot/Serial Numbers: MF7044497 MF7054982 MF7076013 MF7086515 MF7086964 MF7097339 MF7097388 MF7107535 MF7128358 MF7128419 MF7128466 MF8018705 MF8018706 MF8018707 MF8018725 MF8018726 MF8018729 MF8018846 MF8018847 MF8018848 MF8018924 MF8018925 MF8018998 MF8018999 MF8019101 MF8019102 MF8029111 MF8029166 MF8029167 MF8029168 MF8029256 MF8029257 MF8029258 MF8039704 MF8039705 MF8039706 MF8039707 MF8039709 MF8040286 MF8040326 MF8040543 MF8040641 MF8050720 MF8050721 MF8050722 MF8050806 MF8050912 MF8050913 MF8050982 MF8050995 MF8050996 MF8061126 MF8061177 MF8061185 MF8061405 MF8061406 MF8061457 MF8061501 MF8071783 MF8071784 MF8071785 MF8071786 MF8071853 MF8071854 MF8071864 MF8072072 MF8082151 MF8082395 MF8082396 MF8082397 MF8092764 MF8092786 MF8093003 MF8103157 MF8103158 MF8103640 MF8113837 MF8113838 MF8113839 MF8113840 MF8113949 MF8113950 MF8124161 MF8124179 MF8124202 MF8124179 MF8124202 MF8124309 MF8124340 MF8124410 and MF8124411;
 
i) Lot/Serial Numbers: MF7012650 MF7065398 MF7076011 MF7086585 MF7086981 MF7097060 MF7097473 MF7107623 MF7117871 MF7128553 MF8018756 MF8018814 MF8019001 MF8019036 MF8029114 MF8029190 MF8039773 MF8039989 MF8040133 MF8050762 MF8050763 MF8050985 MF8051093 MF8061455 MF8071620 MF8082323 MF8082324 MF8082325 MF8092832 MF8103260 MF8124197 MF8124198 and MF8124282;
 
j) Lot/Serial Numbers: MF6090326 MF6101289 MF7012817 MF7065399 MF7065882 MF7076380 MF7086744 MF7097061 MF7097113 MF7097319 MF7097474 MF7118038 MF7118039 MF7128469 MF7128554 MF7128555 MF7128556 MF8018842 MF8018976 MF8019000 MF8019100 MF8029244 MF8029295 MF8029296 MF8029509 MF8039793 MF8039794 MF8039988 MF8040431 MF8040432 MF8040433 MF8040445 MF8040601 MF8040602 MF8040603 MF8050760 MF8050761 MF8050986 MF8050987 MF8050988 MF8051091 MF8051092 MF8061324 MF8061325 MF8061456 MF8071619 MF8071627 MF8071628 MF8071789 MF8071849 MF8072043 MF8082319 MF8082320 MF8082321 MF8082322 MF8092737 MF8092833 MF8092870 MF8092871 MF8092872 MF8092873 MF8103163 MF8103164 MF8103165 MF8103166 MF8103167 MF8103168 MF8103568 MF8103569 and MF8103165;
 
k) Lot/Serial Numbers: MF7076413 MF7086743 MF7097191 MF8092738 MR8039844 and MF8124297;
 
l) Lot/Serial Numbers: MF8082119 MF8092600 MF8103515 and MF8113761;
 
m) Lot/Serial Number: MF8082120
RECALLING FIRM/MANUFACTURER 
Arrow International, Inc., Everett ,  MA , by letter dated February 2, 2009, February 9, 2009, February 6, 2009 and February 10, 2009. Firm initiated recall is ongoing.
REASON 
A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.
VOLUME OF PRODUCT IN COMMERCE 
61,778 total units
DISTRIBUTION 
Nationwide and Argentina , Australia , Taiwan , Singapore , New Zealand , India , Brazil , Belgium , Korea , Peru , Finland , and Denmark

 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II 
___________________________________ 
PRODUCT 
Stryker Trio Small Offset Connector Non Sterile; The Trio Spinal Fixation Systems are pedicle screws systems intended for use in providing immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic lumbar, and sacral spine: degenerative spondyolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion. Catalog Number 48902015; Recall # Z-0986-2009
CODE 
Lot codes: 056254, 056255, 056256, 056257, 56258, 056259, 058065, 05A140, 05A142, 058066, 05A139, 05A141, 058915, 05A143, 05A145, 05A146, 05A144, 061075, 061077, 061551, 061072, 061076, 0615550, 061549, 061760, 05A148, 05A149, and 05A147
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Stryker Spine, Allendale , NJ , by letter dated September 12, 2006.
Manufacturer: Stryker Spine, Cestas, France . Firm initiated recall is complete.
REASON 
Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.
VOLUME OF PRODUCT IN COMMERCE 
2,417 units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. CADD Medication Cassette Reservoirs are intended for use with the CADD Ambulatory Infusion Pumps used for delivering drug therapy and anesthesia to patients. The pumps can be used by home care patients and in a healthcare facility, Recall # Z-0987-2009
CODE 
Lot Numbers: 213X18 and 214X18
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Smiths Medical MD, Inc., Saint Paul ,  MN , by letter on December 8, 2008.
Manufacturer: Smiths Healthcare Manufacturing S.A. De C.V., Tijuana BC , Mexico . Firm initiated recall is ongoing.
REASON 
Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs. If a leak occurs in a CADD medication Cassette Reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the Reservoir. Smiths Medical has not received any report of patient injuries due to these leakages.
VOLUME OF PRODUCT IN COMMERCE 
17,868 cassettes ( 1,489 boxes 12 cassettes/box)
DISTRIBUTION 
PA and countries of El Salvador , Australia , France , Finland , Sweden , and Germany
___________________________________ 
PRODUCT 
a) Deltec Cozmo Insulin Pump, Model 1800. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients but, can also be used in a healthcare facility, Recall # Z-0988-2009;
 
b) Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients, but can also be used in a healthcare facility, Recall # Z-0989-2009
CODE 
a) Product Numbers: 21-1801-51 21-1801-81 21-1803-51 21-1803-81 21-1804-51 21-1804-81 21-1805-137 21-1805-138 21-1805-29 21-1805-49 21-1805-51 21-1805-81 21-1806-137 21-1806-138 21-1806-29 21-1806-49 21-1806-51 21-1806-81 21-1807-137 21-1807-138 21-1807-29 21-1807-49 21-1807-51 21-1807-81 21-1815-01 21-1815-135 21-1815-50 21-1816-01 21-1816-135 21-1816-50 21-1817-01 21-1817-135 21-1817-50 21-1825-81 21-1826-81 and 21-1827-81;
 
b) Product Numbers: 21-1705-79 21-1705-89 21-1706-79 21-1706-89 21-1707-79 21-1707-89 21-1715-19 21-1716-19 and 21-1717-19
RECALLING FIRM/MANUFACTURER 
Smiths Medical MD, Inc., Saint Paul , MN , by letter dated November 20, 2008. Firm initiated recall is ongoing.
REASON 
There have been adverse events reported that the amount of Extended Bolus delivered was not accurately displayed by the Pump. The amount of extended Bolus displayed on the Pump Home Screen 2 and in the Bolus Summary Report is less than what was programmed by the user. In these events, the Pumps delivered the correct amount of insulin as programmed by the user. If the user programs an additional Bolus based solely on the extended Bolus delivered amount displayed on the Bolus Summary Report or Home Screen 2, there is a risk of hypoglycemia.
VOLUME OF PRODUCT IN COMMERCE 
17,047 units
DISTRIBUTION 
Nationwide and countries of Australia, New Zealand, United Kingdom, Ireland, Canada, China, Greece, Poland, Slovenia, Sweden, Israel and Brazil
___________________________________ 
PRODUCT 
a) GE Healthcare Infinia, Model Numbers: a) ASM000886, b) ASM001333, c) ASM001391, d) ASM001465, e) ASM001473, f) ASM001620, g) ASM500016, h) H3000WM, i) H3000WT, j) H3000WY and k) SYS000041. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1001-2009;
 
b) GE Healthcare Infinia Hawkeye, Model Numbers: a) H3000WR, b) H3000WW, c) H3000WZ, d) H3000YM and e) H3000YS. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1002-2009;
 
c) GE Healthcare Infinia Hawkeye 4, Model Numbers: a) 5178728, b) ASM500060, c) H3000WC and d) H3000WD. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, Recall # Z-1003-2009
CODE 
a) Lot Numbers: 16017 16004 16007 16012 16006 16008 16010 16023 16039 16026 16025 16015 16052 16022 16055 16065 16027 16142 16084 16101 16030 16054 16079 16042 16064 16062 16109 16060 16100 16097 16129 16125 16130 16160 16110 16136 16151 16161 16145 16184 16173 16156 16080 16178 16126 16113 16096 16107 16170 16003 16059 17049 17029 17061 17050 17052 17046 17029 17068 and 17154;
b) Lot Numbers: 16001 16049 16043 16040 16028 16009 16051 16053 16044 16037 16015 16099 16035 16048 16020 16053 16013 16026 16036 and 16014; c) Lot Numbers: 16063 16076 16073 16102 16106 16088 16075 16122 16124 16074 16120 16083 16149 16152 16056 16150 16153 16105 16162 16182 16163 16166 16188 16132 16058 16167 16131 16216 16168 16217 16221 16179 16164 16094 16169 16187 16090 16172 16177 16175 16093 16183 16186 16091 16246 16238 16041 16174 16104 16050 16073 16140 16078 16139 16158 and 16067; d) Lot Numbers: 16195 16192 16205 16198 16212 16219 16210 16206 16193 16227 16270 16273 16203 16267 16281 16288 16200 16313 16342 16294 16330 16286 16303 16327 16299 16332 16243 16252 16333 16290 16364 16360 16339 16335 16344 16245 16381 16385 16176 16377 16362 16366 16388 16320 16334 16399 16384 16380 16412 16413 16411 16236 16369 16432 16428 16289 16404 16405 16408 16256 16414 16429 16365 16427 16433 16394 16343 16230 16441 16426 16443 16435 16439 16470 16471 16391 16223 16466 16475 16376 16464 16455 16511 16349 16510 16514 16515 16500 16532 16451 16538 16493 16533 16537 16547 16487 16395 16482 16505 16528 16517 16549 16560 16529 16508 16520 16564 16445 16438 16476 16278 16378 16347 16211 16415 and 16421; e) Lot Numbers: 16254 16276 16316 16314 16308 16283 16323 16298 16326 16284 16280 16262 16345 16331 16291 16337 16312 16352 16371 16346 16355 16368 16315 16356 16266 16379 16410 16398 16321 16416 16293 16340 16374 16429 16318 16406 16420 16319 16456 16440 16450 16449 16477 16460 16329 16302 16492 16474 16448 16499 16498 16490 16478 16430 16494 16496 16309 16400 16491 16452 16419 16328 16397 16462 16191 16418 and 16495; f) Lot Numbers: 16581 16574 16592 16645 16632 16622 16611 16661 16668 16595 16625 16587 16656 16708 16629 16638 16566 16663 16617 16694 16721 16692 16673 16742 16702 16738 16675 16745 16725 16715 16719 16688 16613 16726 16704 16714 16777 16674 16776 16805 16645 16770 16782 16759 16791 16837 16798 16836 16830 16842 16766 16853 16616 16577 16847 16835 16857 16851 16860 16824 16858 16834 16653 16818 16894 16752 16736 16883 16655 16870 16875 16896 16594 16902 16801 16868 16881 16909 16943 16897 16941 16939 16942 16819 16867 16810 16877 16940 16890 16839 16980 16668 16989 16740 16717 16956 16997 17083 16923 17022 16996 16705 17039 and 16695; g) Lot Numbers: 16501 16522 16534 16535 16576 16575 16553 16516 16506 16562 16557 16542 16541 16551 16602 16573 16614 16583 16586 16571 16607 16569 16578 16621 16649 16635 16669 16593 16639 16647 16681 16660 16580 16684 16679 16677 16686 16646 16657 16667 16637 16693 16699 16689 16665 16654 16676 16666 16697 16718 16610 16701 16563 16716 16579 16424 16710 16698 16707 16733 16747 16584 16706 16709 16765 16239 16605 16725 16741 16768 16749 16751 16779 16746 16750 16792 16773 16536 16780 16790 16769 16600 16797 16814 16817 16807 16802 16601 16690 17030 and 16815; h) Lot Number: 16353; i) Lot Numbers: 16115 16207 16224 16229 16220 16208 16235 16244 16234 16250 16279 16295 16269 16301 16285 16293 16324 16255 16271 16370 16233 16372 16422 16442 16382 16437 16453 16425 16457 16454 16465 16259 16469 16509 16519 16497 16527 16479 16531 16524 16434 16489 16567 16539 16502 16446 16311 16627 16640 16608 16636 16641 16634 16540 16659 16628 16643 16658 16209 16228 16685 16626 16513 16548 16664 16672 16559 16670 16662 16720 16696 16734 16713 16763 16735 16748 16761 16767 16775 16803 16762 16536 16783 16812 16310 16392 16731 16788 16728 16723 16214 16504 16799 16502 16249 16503 16756 16760 16680 16376 16518 16612 16525 16300 16297 16447 16732 16786 16710 16758 16786 16731 16213 16808 16804 16135 16848 16800 16833 16816 16806 16789 16822 16841 16840 16839 16829 16832 16437 16587 16866 16861 16863 16825 16900 16916 16872 16882 16908 16917 16772 16929 16935 16920 16778 16959 16964 16196 16263 16305 16913 16526 16648 16796 16991 16912 17003 17031 17006 17056 17012 16971 16983 16851 17009 17027 17073 17014 17074 17064 17043 17117 17080 17155 17059 17142 17160 17152 17123 16296 16904 17146 17212 17177 17216 17218 17015 17223 16993 16218 17184 17234 17246 17275 17282 17274 17257 17279 17291 17134 17270 17196 17308 17302 17230 16984 17261 17334 17355 17315 17242 17168 17283 16973 17378 17371 17380 17393 17409 17396 17292 17221 17186 and 16483; j) Lot Numbers: 16282 16204 16423 16143 16423 and 17085 and k) Lot Numbers: 16005 16034 16018 16045 16092 16016 16123 16098 16072 16084 16111 16136 16108 16155 16116 16180 16189 16185 and 16137;
 
b) a) Lot Numbers: 16306 and 16275; b) Lot Numbers: 16086 16202 16231 16241 16268 16265 16247 16277 16201 16272 16274 16258 16278 16242 16257 16341 16307 16232 16351 16358 16363 16383 16134 16383 16367 16095 16359 16338 16390 16407 16253 16463 16242 16461 16484 16467 16472 16486 16393 16488 16507 16545 16459 16546 16523 16550 16521 16402 16417 16599 16556 16480 16558 16597 16555 16590 16603 16598 16606 16618 16630 16596 16530 16619 16609 16631 16623 16691 16708 16620 16633 16642 16599 16703 16591 16671 16764 16757 16604 16787 16615 16287 16690 16568 16458 16711 16727 16386 16729 16444 16260 16678 16687 16588 16700 16653 16730 16782 16824 16342 16879 16003 16801 16884 16292 16906 16892 16931 16952 16954 16222 16936 16895 16257 16951 16373 16958 16389 16982 16981 17038 16754 16985 16998 16855 16458 16644 and 16544; c) Lot Numbers: 16237 16350 16251 16375 16387 16512 16565 16582 16403 16240 16183 16572 16485 16552 16248 16215 16261 16197 16468 16361 16624 16813 16409 16831 16481 16240 16264 16891 16961 16826 and 17148; d) Lot Numbers: 16046 16011 16021 16057 16027 16128 16077 16097 16019 16103 16082 16112 16029 16121 16157 16148 16159 16038 16147 16146 16127 16154 16174 16024 and 16133 and e) Lot Numbers: 16068 16089 16141 16085 and 16061;
 
c) a) Lot Numbers: 17445 17001 17035 17023 17008 16988 17007 17010 17063 17077 17053 16995 17088 17098 17090 16990 17054 17099 17081 17060 17128 17140 17116 17004 17089 17036 17045 17129 17130 17108 17093 17171 17144 17158 17069 17135 17040 17172 17132 17183 17153 17201 17182 17111 17190 17187 17175 17169 17133 17213 17166 17104 17203 17141 17204 17139 17113 17224 17226 17228 17210 17229 17119 17255 17239 17233 17002 17266 17245 17276 17264 17248 17094 17256 17273 17254 17281 17294 17305 17277 17250 17252 17287 17307 17325 17285 17317 17288 17272 17299 17220 17321 17329 17341 17314 17293 17335 17328 17286 17366 17350 17306 17342 17096 17365 17309 17364 17349 17339 17369 17300 17390 17387 17361 17394 17376 17403 17359 17437 17415 17389 17382 17435 17423 17304 17449 17297 and 17241; b) Lot Numbers: 16821 16820 16846 16865 16852 16862 16880 16774 16893 16888 16874 16924 16928 16927 16933 16926 16937 16934 16938 16844 16930 16969 16962 16963 16977 16925 16901 16945 17005 16986 16914 17020 16944 16885 17034 17019 16949 17057 17055 17058 16976 16965 16976 17047 16987 and 17070;
c) Lot Numbers: 16838 16849 16856 16850 16876 16869 16878 16811 16871 16889 16905 16898 16911 16921 16922 16910 16932 16886 16974 16955 16887 16919 16978 16968 16947 16979 16967 16972 16966 16970 17011 16994 17024 16950 17048 17042 17062 17018 17082 17105 17106 17000 17100 17125 17121 17025 17136 17122 17118 17041 17131 17103 17174 17164 17109 17197 17101 17114 16960 17199 17198 17124 17195 17179 17112 17185 17219 17238 17178 17247 17173 17265 16975 17259 17298 17260 17301 17278 17231 17165 17289 17290 17295 17333 17251 17338 17337 16946 17348 17373 17363 17347 17323 17326 17430 17416 17429 17415 17208 17422 17450 17258 and 17249; and d) Lot Numbers: 17072 17126 17067 17107 17163 17236 17346 and 17379
RECALLING FIRM/MANUFACTURER 
Recalling Firm: GE Medical Systems, LLC, Waukesha , WI , by letter dated April 2008.
Manufacturer: GE Medical System, Tirat Hacarmel   30200 , Israel . Firm initiated recall is ongoing.
REASON 
GE Healthcare has recently become aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye, Infinia Hawkeye 4) that may impact patient safety. It was reported at a customer site that the pressure used to activate the Pressure Sensitive Device (PSD) should be lowered and that the body contouring software requires correction to prevent possible patient injury during operation. This resulted in a patient receiving a broken nose during a whole body scan while using the Auto Body Contour software option.
VOLUME OF PRODUCT IN COMMERCE 
1,256 units
DISTRIBUTION 
AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VT, VA, WA, WV and WI and countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungry, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Georgia, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine and the United Kingdom
___________________________________ 
PRODUCT 
Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures, Recall # Z-1004-2009
CODE 
Lot Numbers: 08FM05400 and 08FM05400B
RECALLING FIRM/MANUFACTURER 
Smith & Nephew Inc., Memphis ,  TN , by e-mail dated November 24, 2008. Firm initiated recall is ongoing.
REASON 
Liners measuring 28 mm ID and were mismarked as 32 mm.
VOLUME OF PRODUCT IN COMMERCE 
19 units
DISTRIBUTION 
Canada , France , Germany and Switzerland
___________________________________ 
PRODUCT 
a) AxSYM HBsAg Reagent Pack; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes); list 9B01-20, Recall # Z-1046-2009;
 
b) AxSYM CMV IgG Reagent Pack; The AxSYM CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to cytomegalovirus in human serum and plasma (EDTA, heparin or sodium citrate) as an indication of past or current infection with cytomegalovirus; list 4B47-20, Recall # Z-1047-2009;
 
c) AxSYM CORE 2.0 Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM CORE 2.0 is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of total antibodies (IgG and IgM) to hepatitis B virus core antigen (anti-HBc) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes containing lithium heparin); list 8B88-20, Recall # Z-1048-2009;
 
d) AxSYM Folate Reagent Pack; AxSYM Folate is an ion capture assay for the quantitative determination of folate in human serum, plasma or red blood cells on the AxSYM System; list 3C81-20, Recall # Z-1049-2009;
 
e) AxSYM Myoglobin Reagent Pack; AxSYM Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma on the AxSYM System; list 3E43-20, Recall # Z-1050-2009;
 
f) AxSYM Troponin-I ADV Reagent Pack; AxSYM Troponin-I ADV is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnI) in human serum or plasma on the AxSYM System; list 2J44-22, Recall # Z-1051-2009
CODE 
a) Lot Number: 66495M100;
b) Lot Number: 66577M100;
c) Lot Number: 66253M200;
d) Lot Number: 68537M100;
e) Lot Number: 63493M200;
f) Lot Numbers: 67320M100 and 67320M101;
RECALLING FIRM/MANUFACTURER 
Abbott Laboratories, Abbott Park , IL , by letter on January 19, 2009. Firm initiated recall is ongoing.
REASON 
Defective caps; Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.
VOLUME OF PRODUCT IN COMMERCE 
10,123 kits
DISTRIBUTION 
Nationwide, Germany , Mexico , Hong Kong, and Japan
___________________________________ 
PRODUCT 
a) AxSOS T8 Screwdriver, 3.0mm Locking Set; REF 702746. This product is non sterile. The screwdrivers of the AxSOS system are multiple use instruments used to insert screws into bones, Recall # Z-1062-2009;
 
b) AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set; REF 702749. This product is non sterile. The torque limiter is used for final tightening locking screws to the plate in order to avoid over tightening of the locking screws, Recall # Z-1063-2009
CODE 
All lot codes
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah , NJ , by letters on November 24, 2008.
Manufacturer: Stryker Trauma AG, Selzach , Switzerland . Firm initiated recall is ongoing.
REASON 
Potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.
VOLUME OF PRODUCT IN COMMERCE 
882 units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
a) ALM Prismatic Surgical Light 9551 DF; Maquet SA. ALM Prismatic (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures; Article Number: 567014999, Recall # Z-1153-2009;
 
b) ALM Prismatic Surgical Light 54004 SF; Maquet SA. ALM Prismatic (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures; Article Number: 567030999, Recall # Z-1154-2009
CODE 
a) Serial Numbers: 1104, 1105, 1106, 25163, 25340, 25341, 25890, 26012, 26417, 26418, 26686, 27251, 27753, 27854, 27855, 28096, 28097, 28813, 29652, 29950, 30087, 30152, 30333-30334, 30739, 31250, 31381, 32333, 32334, 32336, 32580, 32708, 32709 and 32800;
 
b) Serial Numbers: 6041, 6042, 6043, 6044, 6045, 6046, 6047, 6048, 6049, 6050, 6051, 6052, 6053, 6054, 6057, 6058, 6059, 6060, 6061 and 6062
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Maquet, Inc., Bridgewater , NJ , by letter dated February 23, 2009.
Manufacturer: Maquet S.A. , Orleans Cedex 2, France. Firm initiated recall is ongoing.
REASON 
The screws holding the Prismatic triple surgical lights may break due to dynamic multidirectional bending stress. The firm has received one complaint report.
VOLUME OF PRODUCT IN COMMERCE 
54 units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; Outer box labeled as Smiths Medical. The NurseMate Remote Review Station is an integrated review station for the EP WorkMate Computer recording system that allows a separate user to review and edit patient study date stored on the SP Work Mate System and monitor patient data from the EP WorkMate during a Patient study. Smith Medical Part Number: 87-1785-0000, Recall # Z-1156-2009
CODE 
Serial Numbers: AM08080015, AM08080016, AM08080017, AM08080018, AM08080019, AM08100004, AM08100005, AM08100006, AM08100007 and AM08100008
RECALLING FIRM/MANUFACTURER 
Recalling Firm: EP Medsystems, Inc., West Berlin , NJ , by letters dated January 16, 2009 and February 13, 2009.
Manufacturer: Smiths Medical PM, Inc., Waukesha , WI . Firm initiated recall is ongoing.
REASON 
There is a risk that the monitor may not be adequately secured to the stand, resulting in the monitor falling off which may cause injury.
VOLUME OF PRODUCT IN COMMERCE 
4 units
DISTRIBUTION 
CA, NV, FL
___________________________________ 
PRODUCT 
Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor; Part Number: 0012-00-1589-03 Rev. C, Recall # Z-1198-2009
CODE 
RAM 0827
RECALLING FIRM/MANUFACTURER 
Datascope Corp - Cardiac Assist Division, Mahwah ,  NJ , by visit beginning February 4, 2009. Firm initiated recall is complete.
REASON 
Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Balloon Pump (IABP) and patient monitor does not provide a signal to the patient monitor.
VOLUME OF PRODUCT IN COMMERCE 
20 units
DISTRIBUTION 
IL, FL
___________________________________ 
PRODUCT 
300 microliter CO-RE tips for use with Microlab STAR series instruments, Part Number 235902, 5,760 tips per case. The products are a disposable product that are used with the Microlab STAR series instruments, which are microliter diluting and dispensing devices, Recall # Z-1203-2009
CODE 
Lot Number: 2873900
RECALLING FIRM/MANUFACTURER 
Hamilton Co., Reno ,  NV , by letter dated December 1, 2008. Firm initiated recall is ongoing.
REASON 
Some tips may be occluded and are unable to aspirate or dispense liquid.
VOLUME OF PRODUCT IN COMMERCE 
28 cases
DISTRIBUTION 
MA, CA, MN, CT, and NC
___________________________________ 
PRODUCT 
a) Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, Recall # Z-1238-2009;
  
b) Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (an Antimicrobial *Heparin Coating) For use with Vigilance Monitor. REF: 139HF75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, Recall # Z-1239-2009;
  
c) Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC Thromboshield (An Antimicrobial * Heparin Coating) REF: 139HF75P For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, Recall # Z-1240-2009;
  
d) Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2 Thermodilution Catheter with AMC Thromboshield (an Antimicrobial * Heparin Coating); For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 744HF75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, Recall # Z-1241-2009;
  
e) Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746F8; For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, Recall # Z-1242-2009;
  
f) Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter with AMC Thromboshield (An Antimicrobial * Heparin Coating) For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746HF8 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, Recall # Z-1243-2009
CODE 
a) Lot number: 58619364 - expiration date between May 2010 and November 2010;
 
b) Lot number: 58619322 - expiration date between May 2010 and November 2010;
 
c) Lot numbers: 58612687, 58612688, 58614615, 58618629, 58618632, 58619700, 58619701, 58619702, 58621364, 58621568, 58623753, 58623754, 58627920, 58629865, 58632893, 58632895, 58644277, and 58644651;
 
d) Lot numbers: 58612694, 58612695, 58615354, 58615358, 58615361, 58618060, 58618061, 58618062, 58626669, 5862672, 58626679, 58626683, 58629859, 58630224, 58630225, 58630226, 58630227, 58635119, 58636668, 58644190, 58646593, 58646595, and 58646597;

e) Lot number: 58617326;
 
f) Lot numbers: 58612700, 58612702, 58617328, 58617329, 58617330, 58617332, 58617341, 58619706, 58619707, 58619708, 58619709, 58621527, 58621532, 58621535, 58623045, 58623047, 58625221, 58625549, 58627893, 58627899, 58629866, 58630228, 58631725, 58632892, 58633695, 58633696, 58636429, and 58644898
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Edwards Lifesciences, LLC, Irvine ,  CA , by letters dated February 9, 2009.
Manufacturer: Edwards Lifesciences Technology SARL, Anasco, PR. Firm initiated recall is ongoing.
REASON 
Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".
VOLUME OF PRODUCT IN COMMERCE 
10,754 units
DISTRIBUTION 
AL, AR, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Hawaii, and Puerto Rico and countries of Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, UK, Greece, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Portugal, Sweden, Colombia, Australia, and Singapore
___________________________________ 
PRODUCT 
Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. The ViperWire atherectomy guide wire has a shaft diameter of 0.014" and is constructed of stainless steel with a smooth finish and is silicone coated. The spring tip configuration is atraumatic, radiopaque, and can be bent to form a steerable system, Recall # Z-1250-2009
CODE 
Lot number: P1406641
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Cardiovascular Systems, Inc., Arden Hills , MN , by letters on March 16, 2009.
Manufacturer: Lake Region Mfg., Inc., Chaska , MN . Firm initiated recall is complete.
REASON 
Devices recalled due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicated.
VOLUME OF PRODUCT IN COMMERCE 
10 devices
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
Modular Replacement System (MRS) Cemented Stems, Sterile, Catalog Numbers: 6485-3-000, 6485-3-008, 6485-3-009, 6485-3-010, 6485-3-018, 6485-3-019, 6485-3-300, 6485-3-308, 6485-3-309, 6485-3-310, 6485-3-318, and 6485-3-319. The Modular Replacement System has been successfully used in clinical in clinical situations where there is extensive bone loss due to tumor resection, and/or failed previous prosthesis, or trauma. These components can be used to replace the proximal femur, the distal femur, the proximal tibia, or to reconstruct the total femur in extreme clinical situations, Recall # Z-1251-2009
CODE 
All lots
RECALLING FIRM/MANUFACTURER 
Stryker Howmedica Osteonics, Corp., Mahwah , NJ , by letters dated January 30, 2009. Firm initiated recall is ongoing.
REASON 
Instruction for use incorrect: There are no statements or warning on labels or Instructions for Use that 8, 9 and 10 mm diameter MRS Cemented Stems are indicated only for use in the GMRS Proximal Tibial and Distal Femoral Components.
VOLUME OF PRODUCT IN COMMERCE 
1,161 units
DISTRIBUTION 
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III 
___________________________________ 
PRODUCT 
Medtronic Streamline Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, Recall # Z-1173-2009
CODE 
Lot number: JDG880205F
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Medtronic, Inc., Minneapolis , MN , by letter dated February 6, 2009.
Manufacturer: Medtronics France, SA, Fourmies , France . Firm initiated recall is ongoing.
REASON 
This lot of product contains incorrect inner pouch labeling; instead of 6495 it is labeled 6500. The outer carton, shelf box labeling, and instructions for use are correct, and the actual product shipped was consistent with the product ordered. No adverse patient effects have been reported.
VOLUME OF PRODUCT IN COMMERCE 
612 units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
Pointe Scientific Direct Bilirubin Reagent Set. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers. a) HB936-120, and b) HB936-294, Recall # Z-1202-2009
CODE 
a) Lot Number: 731801, exp. 11/2011 and b) Lot Number: 817103, exp. 5/2012
RECALLING FIRM/MANUFACTURER 
Pointe Scientific, Inc., Canton   MI , by letter dated February 2, 2009. Firm initiated recall is ongoing.
REASON 
The product performance fails due to precipitation of the R2 component.
VOLUME OF PRODUCT IN COMMERCE 
24 kits
DISTRIBUTION 
Nationwide, Chile and Mexico
___________________________________ 
PRODUCT 
Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile; REF 800-0611A and 800-0613A. The device is used for the rapid preparation of platelet-poor-plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow, Recall # Z-1207-2009
CODE 
Lot Numbers 337920 and 337930 and Lot Number 337890
RECALLING FIRM/MANUFACTURER 
Biomet, Inc., Warsaw ,  IN , by letter dated March 5, 2009. Firm initiated recall is ongoing.
REASON 
A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.
VOLUME OF PRODUCT IN COMMERCE 
27 kits
DISTRIBUTION 
Nationwide and countries of Germany and Italy
 
END OF ENFORCEMENT REPORT FOR APRIL 22, 2009

 

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