• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for May 7, 2008

Enforcement Report

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.

 
May 7, 2008
08-19

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I


PRODUCT
Acme brand Cinnamon Rolls. The product is sold in a hard plastic container "clamshell" containing 4 cinnamon rolls (net wt 10 oz). The UPC number is 249784001999. The cinnamon rolls are topped with icing. Recall # F-299-8
CODE
All product with a sell by date of Mar 23 08 or earlier
RECALLING FIRM/MANUFACTURER
Recalling Firm: Acme Markets, Malvern, PA, by e-mail on March 18, 2008.
Manufacturer: H. C. Brill Company Inc., Tucker, GA. Firm initiated recall is complete.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
13,905 units
DISTRIBUTION
DE, MD, NJ, and PA


PRODUCT
a) Chocolate candy bars labeled as Charlemagne Chocolatiers Dark Chocolate with
Coffee Bio Organic, 50 g (1.75 oz.), UPC= 5 425001 204038, Recall # F-300-8
b) Chocolate candy bars labeled as Charlemagne Chocolatiers Dark Chocolate with
Cinnamon Bio Organic, 50 g (1.75 oz), UPC= 5 425001 204052, Recall # F-301-8;
c) Chocolate candy bars labeled as Charlemagne Chocolatiers Dark Chocolate with
Orange Bio Organic, 50 g (1.75 oz), UPC= 5 425001 204021, Recall # F-302-8;
d) Chocolate candy bars labeled as Charlemagne Chocolatiers Dark Chocolate with
Green Tea 50 g (1.75 oz), UPC= 5 425001 204045, Recall # F-303-8;
e) Chocolate candy bars labeled as Charlemagne Chocolatiers Dark Chocolate Plain Bio
Organic with Belize Cocoa Chocolate, 50g (1.75 oz), UPC= 5 425001 204014,
Recall # F-304-8
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Belgium's Best Chocolates, Wellesley, MA, by telephone, letter and press release on November 20, 2007.
Manufacturer: Charlemagne Choclatters, Herstal, Belgium. FDA initiated recall is complete.
REASON
Product contains undeclared milk protein.
VOLUME OF PRODUCT IN COMMERCE
59 cases (15 bars)
DISTRIBUTION
MI, CA, NJ, MA


PRODUCT
a) Apple Empanadas, Item 128224, packaged as either a 2-pack (PLU 11988) or a 4-pack
(PLU11989), Recall # F-305-8;
b) Pineapple Empanadas, Item 128226, packaged as either a 2-pack (PLU 11988) or a
4-pack (PLU11989), Recall # F-306-8;
c) Pumpkin Empanadas, Item 128229, packaged as either a 2-pack (PLU 11988) or a
4-pack (PLU11989), Recall # F-307-8
CODE
All codes
RECALLING FIRM/MANUFACTURER
Publix Super Markets, Lakeland, FL, by e-mail and press release on March 14, 2008. Firm initiated recall is ongoing.
REASON
The product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
undetermined
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II


PRODUCT
Zomig (zolmitriptan) tablets, 2.5 mg, unit-dose blister package containing 6 tablets per carton, Rx only, NDC 0310-0210-20, Recall # D-203-2008
CODE
Lot 106033, exp. August 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Astra Zeneca, Wilmington, DE, by letter on April 2, 2008.
Manufacturer: IPR Pharmaceuticals, Inc., Carolina, PR. Firm initiated recall is ongoing.
REASON
Some blister cells may not contain product.
VOLUME OF PRODUCT IN COMMERCE
44,028 blister packs
DISTRIBUTION
Nationwide and Hawaii

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II


PRODUCT
Baxter Fenwal Amicus Separator Apheresis Device, Recall # B-0908-08
CODE
Product code 4R4580, PASSPORT program binders
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fenwal, Inc, Lake Zurich,IL, by letters on May 8 and May 10, 2008.
Manufacturer: Baxter Healthcare Corporation, Largo,FL. Firm initiated recall is complete.
REASON
Fenwal failed to provide users participating in the Post Approval Surveillance Study of Platelet Outcomes, Release Tested (PASSPORT) program with the chart listing the minimum plasma volumes for product containers utilized for 7-day platelet storage.
VOLUME OF PRODUCT IN COMMERCE
8 binders
DISTRIBUTION
AZ, FL, GA, IA, NJ and NY


PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0924-08;
b) Platelets Leukocytes Reduced, Recall # B-0925-08
CODE
a) and b) Unit: 033FN02430
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on October 25, 2007 and by letter dated October 27, 2007. 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
2 units
DISTRIBUTION
CT


PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1160-08
CODE
Units: 125935807 Part 1; 125935807 Part 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone on January 3, 2008.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. 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
2 units
DISTRIBUTION
NM


PRODUCT
Fresh Frozen Plasma, Recall B-1162-08
CODE
Unit: 6735774
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by facsimile on July 6, 2005. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood product contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ


PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1163-08
CODE
Unit: 1676106
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on August 3, 2005 and follow up letter on August 15, 2005. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ


PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1164-08
CODE
Unit: 9217244
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 7, 2007. 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
CO


PRODUCT
Source Plasma, Recall # B-1165-08
CODE
Units: 05MILA4654 and 05MILA4473
RECALLING FIRM/MANUFACTURER
Recalling Firm: Interstate Blood Bank, Inc., Memphis, TN, by facsimile on March 14, 2005.
Manufacturer: Interstate Blood Bank, Inc., of Wisconsin, Milwaukee, WI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred by another donor center, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA


PRODUCT
a) Cryoprecipitated AHF, Recall # B-1166-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1167-08
CODE
a) and b) Units: 307748309
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale,AZ, by telephone and letter on July 20, 2005.
Manufacturer: Blood Systems, Inc., Fargo,ND. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but was collected from a donor that subsequently reported a previous reactive test for Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
ND, SD


PRODUCT
a) Platelets, Recall # B-1168-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1169-08
CODE
a) and b) Units: X8726477
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on June 10, 2005. 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
2 units
DISTRIBUTION
OH, FL


PRODUCT
a) Red Blood Cells, Recall # B-1170-08;
b) Plasma Frozen, Recall # B-1171-08
CODE
a) and b) Units: 1427097
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on March 1, 2006 and by facsimile on April 10, 2006. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from a whole blood unit in which an associated blood component contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ


PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1186-08;
b) Platelets, Recall # B-1187-08
CODE
a) and b) Unit: 4248419
RECALLING FIRM/MANUFACTURER
Florida’s Blood Center, Inc., Orlando, FL, by telephone and facsimile on September 2, 2005. 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
FL


PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1189-08
CODE
Unit: 8543670
RECALLING FIRM/MANUFACTURER
Poudre Valley Health Care, Inc., Blood Bank, Fort Collins, CO, by facsimile dated November 4, 2005. Firm initiated recall is complete.
REASON
Donor reported travel to a malarial endemic area, but was allowed to donate.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO


PRODUCT
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1322-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1323-08
CODE
a) Unit: 9182374;
b) Units: 9182383 (Parts 1 & 2), 9182399 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on July 9, 2007. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were incorrectly tested for white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CO


PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1325-08
CODE
Unit: 003L69997
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by telephone or facsimile on January 4, 2005 and by letter dated January 12, 2005. Firm initiated recall is
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA, Switzerland


PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1329-08
CODE
Unit: 18GT19723
RECALLING FIRM/MANUFACTURER
The American National Red Cross Great Lakes Region, Lansing, MI, by telephone on July 18, 2007 and follow-up letter dated July 25, 2007. 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, MI


PRODUCT
Red Blood Cells, Recall # B-1338-08
CODE
Unit: 3947035
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on March 11, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL


PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1339-08
CODE
Unit: 4770325
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on May 11, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III


PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1161-08
CODE
Unit: 307448453
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on December 21, 2004.
Manufacturer: Blood System, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, in which the quality control testing was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ND


PRODUCT
Source Plasma, Recall # B-1172-08
CODE
Units: I72055952; I72059174; I72059814; I72059934; I72060332; 364004552; 364005502; 364010412
RECALLING FIRM/MANUFACTURER
International BioResources, Llc, Fort Worth,TX, by fax on November 29, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
NC


PRODUCT
Source Plasma, Recall # B-1173-08
CODE
Units: 364011291; 364011590; 364012979
RECALLING FIRM/MANUFACTURER
International BioResources, Llc, Fort Worth,TX, by fax on May 11, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC


PRODUCT
Source Plasma, Recall # B-1174-08
CODE
Units: I72060086; 364004121; 364005123; 364007816; 364009292; 364009978
RECALLING FIRM/MANUFACTURER
International BioResources, Llc, Fort Worth,TX, by fax on November 29, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NC


PRODUCT
Source Plasma, Recall # B-1175-08
CODE
Unit: 364013060
RECALLING FIRM/MANUFACTURER
International BioResources, Llc, Fort Worth,TX, by fax on November 29, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC


PRODUCT
Source Plasma, Recall # B-1176-08
CODE
Unit: 04BNDH3938
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, DeerfieldIL, by fax on May 16, 2005.
Manufacturer: BioLife Plasma Services, L.P., Bismarck,ND. Firm initiated recall is complete.
REASON
Blood product, not quarantined after information was received concerning post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA


PRODUCT
Whole Blood CPD, Recall # B-1321-08
CODE
Units: J41071, J41074, J41076, J41081, J41088
RECALLING FIRM/MANUFACTURER
Central Pennsylvania Blood Bank, Hummelstown, Pa, by facsimile on February 7, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose hemoglobin determinations were incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
PA


PRODUCT
Fresh Frozen Plasma, Recall # B-1324-08
CODE
Units: 04R73046, 04R73049, 04R73050, 04R73051, 04R73054, 04R73055, 04R73056, 04R73057, 04R73060, 04R73065, 04R73067, 04R73070, 04R73073, 04R73074, 04R73076, 04R73078, 04R73079, 04R73081
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by telephone on November 26, 2007 and by letter dated December 4, 2007. Firm initiated recall is complete.
REASON
Blood products, which may have been stored at an incorrect temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
MA, NY, PA


PRODUCT
Recovered Plasma, Recall # B-1326-08
CODE
Unit: 003L69997
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by telephone or facsimile on January 4, 2005 and by letter dated January 12, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA, Switzerland


PRODUCT
Source Plasma, Recall # B-1327-08
CODE
Units GZ047095, GZ046673, GZ046543, GZ046276, GZ046134, GZ045820, GZ043452, GZ043118, GZ018276, GZ018116, 06GINA2726 and 06GINA2687
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Gary, IN, by fax on December 11, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CA and Austria


PRODUCT
Source Plasma, Recall # B-1328-08
CODE
Unit: GZ042249
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Gary, IN, by fax on November 8, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria


PRODUCT
Blood and Blood Products for Reprocessing, Recall # B-1330-08
CODE
Unit: 18GT19723
RECALLING FIRM/MANUFACTURER
The American National Red Cross Great Lakes Region, Lansing, MI, by telephone on July 18, 2007 and follow-up letter dated July 25, 2007. 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, MI


PRODUCT
Recovered Plasma, Recall # B-1340-08
CODE
Unit: 4243496
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc. Orlando, FL, by e-mail on September 15, 2005. Firm initiated recall is complete.
REASON
Blood product, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but was collected from a donor who was subsequently determined to have previously tested positive for HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II


PRODUCT
a) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator,
Catalog Number: 255100; Product Number: M0062551000, Recall # Z-0905-2008;
b) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator,
Catalog Number: 255101; Product Number: M0062551010, Recall # Z-0906-2008;
c) Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator,
Catalog Number: 255102; Product Number: M0062551020, Recall # Z-0907-2008;
d) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator,
Catalog Number: 255103; Product Number: M0062551030, Recall # Z-0908-2008;
e) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator,
Catalog Number: 255104; Product Number: M0062551040, Recall # Z-0909-2008;
f) Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator,
Catalog Number: 255105; Product Number: M0062551050, Recall # Z-0910-2008;
g) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator,
Catalog Number: 255106; Product Number: M0062551060, Recall # Z-0911-2008;
h) Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator,
Catalog Number: 255108; Product Number: M0062551080, Recall # Z-0913-2008
CODE
a) Lot numbers: W03-1606, W03-1649, , W03-1700, W03-1702, W03-1924, W03-2077,
W03-2143, W03-2277, W03-2283;
b) Lot numbers: W03-1527, W03-1579, W03-1587, W03-1595, W03-1623, W03-1644,
W03-1753, W03-1786, W03-1787, W03-1813, W03-1832, W03-1938, W03-2108,
W03-2110, W03-2139, W03-2271, W03-2278, W03-2279, W03-2280, W03-2535,
W03-2589;
c) Lot numbers: W03-1613, W03-1747, W03-1805, W03-1945, W03-2111, W03-2272,
W03-2484, W03-2577;
d) Lot numbers: W03-1473, W03-1474, W03-1909, W03-2055, W03-2112, W03-2144,
W03-2232, W03-2284, W03-2232, W03-2391, W03-2464, W03-2579;
e) Lot numbers: W03-1482, W03-1491, W03-1508, W03-1524, W03-1740, W03-1917,
W03-2107, W03-2113, W03-2214, W03-2216, W03-2236, W03-2239, W03-2240,
W03-2285, W03-2354, W03-2410, W03-2446, W03-2457, W03-2483, W03-2580;
f) Lot numbers: W03-1464, W03-1767, W03-2106, W03-2215, W03-2241, W03-2242,
W03-2275, W03-2470, W03-2566;
g) Lot numbers: W03-2337, W03-2359, W03-2392, W03-2553, W03-2554, W03-2590;
h) Lot Number: W03-2341, W03-2357, W03-2395, W03-2578
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick,MA, by letter on November 29, 2007.
Manufacturer: Onset Medical Corporation, Irvine,CA. Firm initiated recall is ongoing.
REASON
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
VOLUME OF PRODUCT IN COMMERCE
1,998 units (total also includes Recall # Z-0912-2008 – Class III)
DISTRIBUTION
Nationwide


PRODUCT
a) Siemens Coherence AG Therapist, Part No: 5863506, medical charged-particle
radiation therapy system with software version 2.1, Recall # Z-0971-2008;
b) Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle
radiation therapy system with software version 2.1, Recall # Z-0972-2008;
c) Siemens Coherence Impression Therapist system, Part No: 7341410, medical
charged-particle radiation therapy system with software version 2.1,
Recall # Z-0973-2008;
d) Siemens Primeview 3i medical charged-particle radiation therapy system,
Part No: 7341428, with software version 3i, Recall # Z-0975-2008;
e) Siemens AG Therapist 3rd Party V&R medical charged-particle radiation therapy
system, Part No: 7345411, Recall # Z-0975-2008;
f) Siemens Impression Therapist 3rd Party V&R medical charged-particle radiation
therapy system, Part No: 7345429, Recall # Z-0976-2008;
g) Siemens Syngo based WS 3rd Party V&R medical charged-particle radiation
therapy system, Part No: 7345437, Recall # Z-0977-2008;
h) Siemens Coherence Therapist 2.0 medical charged-particle radiation therapy
system, Part No: 8139839, with software version 2.1, Recall # Z-0978-2008;
i) Siemens Primeview 3i 2.0 medical charged-particle radiation therapy system,
Part No: 8139487, with software version 3i 2.0, Recall # Z-0979-2008;
j) Siemens Coherence Therapist 2.1 medical charged-particle radiation therapy system,
Part No: 8147667, with software version 2, Recall # Z-0980-2008;
k) Siemens Primeview 3i 2.1 medical charged-particle radiation therapy system, Part
No: 8147675, with software version 3i, Recall # Z-0981-2008
CODE
a) Serial Numbers: 84601, 84602, 85703, 85714, 85718, 85720, and 00E0815479E1;
b) Serial Numbers: 10007, 10010, 10015, 10017, 10020, 10026, 10028, 10030, 10037,
10038, 10001, 10003, 10004, 10005, 10008, 10009, 10011, 10019, 10027, 10031,
10039, 11004, 11006, 10006, 10018 ,10021, 10022, 10024, 10025, 11005, 10016,
10023, 10029, 10032, 10033, 10035, 10036, 10040, 11001, and 11008;
c) Serial Numbers: 2801, 10201, 14101, 22201, 56302, 57401, 62701, 79102, 93301,
98001, 00E0815462E6, 00E08154754E, 00E081548949, 102001, 1601, and 39901;
d) Serial Numbers: 102301, 104201, 00E0815462E6, 5602, 48701, 57401;
e) Serial Numbers: 24801;
f) Serial Number: 735429;
g) Serial Numbers: 10017;
h) Serial Numbers: 10035, 10037, 15901, 10020, 10030, 10034, 10002;
i) Serial Numbers: 10007, 10021, and 10014;
j) Serial Numbers: 10007, 10010, 10015, 10017, 10020, 10026, 10028, 10030, 10037,
and 10038;
k) Serial Numbers: 3764, 10003, 10014, 10017, 10020, 10005, 10007, 10008, 10010,
10011, 10013, 10028, 10001, 10006, 10022, 10026, 10033, 10002, 10018, 10019,
10021, 10023, 10024, 10025, 10032, 10048
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions, USA, Inc., Concord, CA, by letter on October 3, 2007. Firm initiated recall is ongoing.
REASON
Image Orientation Incorrect (Image Shifts) - 1) if the reference image has been calibrated for centering and the reference image is used for patient positioning, the image will shift when the positioning tools are used. 2) This problem occurs only when non-square reference images are used, such as when images are cropped. At this point, the images will refresh, and the center of the reference image will shift.
VOLUME OF PRODUCT IN COMMERCE
118 units
DISTRIBUTION
Nationwide and Internationally


PRODUCT
Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Recall # Z-1038-2008
CODE
Serial Numbers: 10483, 10651, 10628, 10488, 10605, 10676, 10658, 10421, 10685, 10724, 10584, 10619, 10626, 10629, 10635, 10694, 10706, 10438, 10600, 10668, 10655, 10436, 10606, 10702, 10433, 10558, 10636, 10642, 10692, 10698, 10412, 10440, 10539, 10613, 10674, 10621, 10634, 10583, 10684, 10476, 10414, 10664, 10671, 10712, 10472, 10567, and 10641
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern,PA, by letter dated December 21, 2007
Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany. Firm initiated recall is ongoing.
REASON
Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.
VOLUME OF PRODUCT IN COMMERCE
47 units
DISTRIBUTION
Nationwide


PRODUCT
Seradyn QMS Vancomycin reagents, Part Number: 0373589, Recall # Z-1102-2008
CODE
All lots (lots 501930, 502063, 502074, 600432, 601166, 601207, 602556, 603076, 603801, 603312, 700657 and 703027)
RECALLING FIRM/MANUFACTURER
Seradyn, Inc., Indianapolis,IN, by letter dated December 20, 2007. Firm initiated recall is ongoing.
REASON
False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.
VOLUME OF PRODUCT IN COMMERCE
1,819 kits plus bulk material for 1,863 kits
DISTRIBUTION
Nationwide and Internationally


PRODUCT
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis, Recall # Z-1104-2008
CODE
Software versions 2.1.X. and 3.0.X
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated December 28, 2007. Firm initiated recall is ongoing.
REASON
Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe [']). This may not be evident to the end user, as the symbols only appear when the Exam Note window is open.
VOLUME OF PRODUCT IN COMMERCE
423 units nationwide; 134 units internationally
DISTRIBUTION
Nationwide and Internationally


PRODUCT
Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Recall # Z-1106-2008
CODE
Lots 05167CG2, 05192012, 05223012 and 06335012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Div. of Stryker Corporation, Portage, MI, by letter dated January 10, 2008.
Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR. Firm initiated recall is ongoing.
REASON
Sterility may be compromised, as the packaging may have channels in the packaging seal.
VOLUME OF PRODUCT IN COMMERCE
25 boxes of 6
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III


PRODUCT
Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Recall # Z-0912-2008
CODE
Lot numbers: W03-2339, W03-2342, W03-2362, W03-2382, W03-2409, W03-2431, W03-2434, W03-2436, W03-2439, W03-2479, W03-2482, W03-2550, W03-2555, W03-2581, W03-2591
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick,MA, by letter on November 29, 2007.
Manufacturer: Onset Medical Corporation, Irvine,CA. Firm initiated recall is ongoing.
REASON
Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
VOLUME OF PRODUCT IN COMMERCE
1,998 units (total also includes Recall # Z-0905/Z-0913-2008 – Class II Recalls)
DISTRIBUTION
Nationwide


PRODUCT
a) Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software
Version 2.1, Automated differential cell counter, Part Number: 626554,
Recall # Z-0958-2008;
b) Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software
Version 2.2, Automated differential cell counter, Part Number 626553,
Recall # Z-0959-2008
CODE
a) Serial numbers: AJ50363, AK25191, AK39273, AJ30194AK02009, AK24144,
AJ32209, AL13073, AJ43303, AK32209, AJ50358, AL17100, AK24164, AJ47338,
AJ13070, AL06029, AJ13071, AK32212, AK32210, AJ39264, AJ43304;
b) Serial Numbers: AL11058, AK20149, AJ37243, AJ08035, AK16130, AK01004,
AJ33215, AK16129, AK25182, AK51355, AL13064, AJ38253, AK51353,
AK07059, AL12062, AJ40271, AJ02008, AJ50371, AK07058, AL21134, AJ01002,
AK12093, AL15085, AL14077, AJ30191, AJ48342, AK20152, AK07060, AJ37246,
AJ06026, AK32539, AJ39259, AL04022, AJ37240, AK48336, AJ46318, AJ14074,
AJ17095, AK34227, AJ47331, AJ48341, AJ33210, AK48347, AK20158, AK12095,
AK16131, AK19146, AK17138, AJ25164, AJ24147, AJ51381, AJ48339, AK51359,
AJ49351, AL14082, AL22140, AJ24155, AJ47332, AK51358, AL23144, AJ24151,
AJ49348, AK51380, AJ38250, AK48343, AK17135, AK18141, AK09075, AK13103,
AJ29184, AJ30189, AJ02006, AJ14075, AJ14073, AJ15079, AJ16087, AJ16085,
AJ15078, AJ16083, AJ19103, AJ19111, AJ21116, AJ19109, AJ21114, AJ21115,
AJ21117, AJ22121, AJ22122, AJ23135, AJ25165, AJ24156, AJ25159, AJ24154,
AJ25167, AJ25161, AJ47327, AK07062, AK33215, AL18108, AL20125, AJ17091,
AK34232, AJ25160, AJ25163, AK05025, AJ29181, AJ50366, AK48328, AJ44313,
AK51370, AK34230, AJ38248, AL19111, AJ12063, AJ44309, AJ22124, AK08071,
AK48334, AK25177, AJ48344, AJ42294, AK51372, AL12063, AJ24158, AJ46319,
AJ43298, AK30199, AK20153, AK51354, AJ31195, AJ49349, AJ12064, AK33225,
AJ35229, AK17140, AJ29183, AK16127, AJ36234, AK17134, AL09044, AJ48340,
AK19147, AK39264, AL21133, AL06033, AJ19110, AJ10048, AK51361, AJ24148,
AJ50368, AJ11056, AJ34221, AJ03012, AK19148, AK06051, AK34233, AK39246,
AJ14072, AJ44316, AJ42292, AK48338, AK34229, AJ29182, AK18139, AK08066,
AK44284, AJ05020, AK30204, AK08063, AJ34217, AJ23129, AJ23134, AJ34226,
AJ37238, AK25181, AK34231, AK34228, AK34234, AK48342, AJ24142, AK39266,
AJ47326, AL21135, AJ07032, AL16093, AJ38251, AJ38252, AJ43300, OAK48341,
AJ23138, AJ25166, AL23145, AK39273, AJ30194, AK02009, AJ24144, AJ32209,
AL13073
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on June 29, 2007.
Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is complete.
REASON
Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.
VOLUME OF PRODUCT IN COMMERCE
516 units nationwide; 73 units in Canada
DISTRIBUTION
Nationwide and Canada


PRODUCT
Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Recall # Z-1037-2008
CODE
Lot Number: G8677
RECALLING FIRM/MANUFACTURER
Recalling Firm: Straumann Usa, Llc, Andover, MA, by letter on January 10, 2008.
Manufacturer: Instituit Strauman, Basel, Switzerland. Firm initiated recall is ongoing.
REASON
Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR MAY 7, 2008

###