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U.S. Department of Health and Human Services

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Enforcement Report for April 8, 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 8, 2009
09-14

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II 
___________________________________ 
PRODUCT 
a) HTY brand Almond Cookie, Item # 7ALCO (6.6 oz package), UPC: 076487961530; Undeclared allergen: Wheat, Recall # F-168-9;
 
b) HTY brand Sun Cake, Item # 7SUN (6 oz package), UPC: 076487890809. Undeclared allergen: Wheat, Recall # F-169-9;
 
c) HTY brand Green Bean Cake, Item # 7GRSS (15 pc 6.7 oz package), UPC: 076487962452; Undeclared allergens: Wheat and FD&C Yellow # 5, Recall # F-170-9
CODE 
a) Julian dates: 8315 through 8322, 9017;
b) Julian dates: 8316 through 8318, 8358 through 8361;
c) Julian dates: 8343, 8344, 9018 through 9023
RECALLING FIRM/MANUFACTURER 
Mese Hsin Tung Yang Food Co., San Francisco, CA, by letter on February 5, 2009. Firm initiated recall is ongoing.
REASON 
Products contain undeclared wheat and undeclared color, FD&C Yellow # 5.
VOLUME OF PRODUCT IN COMMERCE 
70 cases/840 units
DISTRIBUTION 
CA
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II 
___________________________________ 
PRODUCT 
a) MS Extended-Release Tablets, 15 mg, Each Tablet Contains: MS 15 mg, Caution: For Further Manufacturing, Processing or Repacking, Not For Sale in the United States (Export Only), Rx Only, Recall # D-230-2009;
 
b) MS Extended-Release Tablets, 30 mg, Each Tablet Contains: MS 30 mg, Caution: For Further Manufacturing, Processing or Repacking, Not For Sale in the United States (Export Only), Rx Only, Recall # D-231-2009:
 
c) MS Extended-Release Tablets, 60 mg, Each Tablet Contains: MS 60 mg, Caution: For Further Manufacturing, Processing or Repacking, Not For Sale in the United States (Export Only), Rx Only, Recall # D-232-2009
CODE 
a) Lot numbers: 91331 and 99750;
b) Lot number: 98383;
c) Lot number: 98384
RECALLING FIRM/MANUFACTURER 
KV Pharmaceutical Co., Saint Louis , MO , by press release and letter dated January 28, 2009. Firm initiated recall is ongoing.
REASON 
The products were not manufactured in conformance with GMP's.
VOLUME OF PRODUCT IN COMMERCE 
2,625,203 doses
DISTRIBUTION 
Canada
  
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III 
___________________________________ 
PRODUCT 
Seroquel XR (quetiapine fumarate) extended-release tablets, 50 mg, Once Daily, Professional Sample, Not to be sold, Rx only, supplied in four tablet blister card, one card per carton, NDC 0310-0280-94. Made in Sweden , Recall # D-233-2009
CODE 
Lot number: TA5014
RECALLING FIRM/MANUFACTURER 
Recalling Firm: AstraZeneca Pharmaceuticals LP, Wilmington , DE , by letter dated March 6, 2009.
Manufacturer: AstraZeneca, Sodertalje , Sweden . Firm initiated recall is ongoing.
REASON 
The incorrect Product Insert (Prescribing Information) was included with shipments of Seroquel XR 50 mg samples.
VOLUME OF PRODUCT IN COMMERCE 
255,953 blister packs
DISTRIBUTION 
Nationwide
________________________________ 
PRODUCT 
a) Ny-Tannic (Phenylephrine Tannate 25 mg, Chlorpheniramine Tannate 9 mg), 100 count bottles Rx Only, NDC 28595-0610-01, UPC N328595-610-01, Recall # D-234-2009;
 
b) Vazotan Suspension, 4 fl oz (118 mL) each 5 mL contains: Phenylephrine HCl 10 mg, Brompheniramine Maleate 6 mg, Carbetapentane Citrate 25 mg, Rx Only, NDC 66992-220-04, UPC N366992-220-04, Recall # D-235-2009
CODE 
a) Lot numbers: FRT005, HRT001, and HRT002;
b) Lot numbers: FPC029, FPC029B, and HPC001
RECALLING FIRM/MANUFACTURER 
by letter dated February 17, 2009. Firm initiated recall is ongoing.
REASON 
Stability data does not support expiry date.
VOLUME OF PRODUCT IN COMMERCE 
39,305 Bottles
DISTRIBUTION 
MS
___________________________________ 
PRODUCT 
Cimetidine Hydrochloride Oral Solution, 300 mg/5 mL*, 16 oz bottles, Rx only, NDC 0121-0649-16, Recall # D-236-2009
CODE 
Lot number
RECALLING FIRM/MANUFACTURER 
Pharmaceutical Associates, Inc., Greenville , SC , by letter on/about February 26, 2009. Firm initiated recall is ongoing.
REASON 
Mislabeled; expiration date on the bottle incorrectly coded as "09/10", rather than the correct expiration, "10/09."
VOLUME OF PRODUCT IN COMMERCE 
690 Bottles
DISTRIBUTION 
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________ 
PRODUCT 
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0531-09;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0532-09;
c) Red Blood Cells Leukocytes Reduced, Recall # B-0533-09
CODE 
a) Unit: 017FP09904;
 
b) Units: 017FP10298, 017FP10399, 017FP10399, ( Split Unit), 017FP11138, 017FP11331, 017FP11331 ( Split Unit), 017FQ02828, 017FQ02828 ( Split Unit), 017FQ02829, 017FQ02829 ( Split Unit), 017FQ02858, 017FQ02858 ( Split Unit):
 
c) 017FGS08397, 017FGS08399, 017KZ70222
RECALLING FIRM/MANUFACTURER 
The American National Red Cross, North Central Region, Saint Paul, MN, by facsimile and letter on February 16, 2006. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
16 units
DISTRIBUTION 
MN, NJ, MA
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0568-09
CODE 
Unit: Y59462
RECALLING FIRM/MANUFACTURER 
Virginia Blood Service, Inc., Richmond , VA , by letter on March 10, 2008. Firm initiated recall is complete.
REASON 
Blood product, possibly contaminated with air during collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
VA
___________________________________ 
PRODUCT 
Recovered Plasma, Recall # B-0609-09
CODE 
Unit: 017KT97550
RECALLING FIRM/MANUFACTURER 
The American National Red Cross, North Central Region, Saint Paul, MN, by electronic mail on March 1, 2006. Firm initiated recall is complete.
REASON 
Blood product, which was collected from a donor with a history of high risk behavior and who was unsuitable based on risk factors for Creutzfeldt-Jakob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
IL
___________________________________ 
PRODUCT 
Platelets, Recall # B-0618-09
CODE 
Unit: W044607323523
RECALLING FIRM/MANUFACTURER 
Gulf Coast Regional Blood Center , Houston , TX , by facsimile on October 4, 2007. Firm initiated recall is complete.
REASON 
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
TX
___________________________________ 
PRODUCT 
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0665-09;
b) Platelets, Recall # B-0666-09
CODE 
a) and b) Unit: N98356
RECALLING FIRM/MANUFACTURER 
Michigan Community Blood Centers , Grand Rapids , MI , by fax on July 30, 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
___________________________________ 
PRODUCT 
Red Blood Cells, Recall # B-0668-09
CODE 
Unit: 1642147
RECALLING FIRM/MANUFACTURER 
Community Blood Centers/S Florida, Inc., Lauderhill , FL , by facsimile on February 1, 2005. Firm initiated recall is complete.
REASON 
Blood product, which tested positive for Cytomegalovirus (CMV), but was labeled as negative for CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
FL
___________________________________ 
PRODUCT 
a) Platelets Pheresis Leukocytes Reduced, Recall # B-0675-09;
b) Platelets Pheresis Leukocytes Reduced, Irradiated, Recall # B-0676-09
CODE 
a) Units: 9732215 (2 units);
b) Unit: 9732215
RECALLING FIRM/MANUFACTURER 
Florida 's Blood Centers, Inc., Orlando , FL , by telephone on October 30, 2007 and by follow-up letter dated December 4, 2007. Firm initiated recall is complete.
REASON 
Blood products, which were possibly contaminated with Penicillium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
3 units
DISTRIBUTION 
FL
___________________________________ 
PRODUCT 
Cerner HNA Classic PathNet Blood Bank Donor, versions 306 and 015, 510(k) #BK950055, Recall # B-0677-09
CODE 
Versions 306 and 015
RECALLING FIRM/MANUFACTURER 
Cerner Corp., Kansas City, MO, by website on March 11, 2009, e-mailed on March 12, 2009 and registered mail on March 13, 2009. Firm initiated recall is ongoing.
REASON 
Software with a glitch or defect was distributed.
VOLUME OF PRODUCT IN COMMERCE 
44 units
DISTRIBUTION 
Nationwide, Saudi Arabia and Singapore
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0678-09
CODE 
Unit: 053GQ54706
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , by letter dated March 10, 2008. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor who reported living in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
MD
___________________________________ 
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0681-09;
b) Fresh Frozen Plasma, Recall # B-0682-09
CODE 
a) and b) Unit: N77357
RECALLING FIRM/MANUFACTURER 
Virginia Blood Service, Inc., Richmond , VA , by letter dated April 18, 2008. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor who was taking the drug Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
VA, GA
___________________________________ 
PRODUCT 
Red Blood Cells (Apheresis), Recall # B-0692-09
CODE 
Units: 1553291A, 1553291B
RECALLING FIRM/MANUFACTURER 
Community Blood Centers/S Florida, Inc., Lauderhill , FL , by facsimile on February 9, 2005. Firm initiated recall is complete.
REASON 
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
FL
___________________________________ 
PRODUCT 
Platelets, Recall # B-0693-09
CODE 
Unit: 1699871
RECALLING FIRM/MANUFACTURER 
Community Blood Centers/S Florida, Inc., Lauderhill , FL , by facsimile on January 19, 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 
FL
___________________________________ 
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0699-09
CODE 
Unit: 1645938
RECALLING FIRM/MANUFACTURER 
Community Blood Centers/S Florida, Inc., Lauderhill , FL , by facsimile on September 21, 2005. Firm initiated recall is complete.
REASON 
Blood product, which did not meet the acceptable product specifications, was distributed. Hematocrit/Hemoglobin
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
FL
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0701-09
CODE 
Unit: 53T13351
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone, letter and e-mail March 21, 2008. 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 
MD
___________________________________ 
PRODUCT 
Platelets Leukocytes Reduced, Recall # B-0703-09
CODE 
Unit: Y63832
RECALLING FIRM/MANUFACTURER 
Virginia Blood Service, Inc., Richmond , VA , by letter dated April 22, 2008. Firm initiated recall is complete.
REASON 
Blood product, collected from a donor who takes aspirin daily, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
VA
___________________________________ 
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0704-09;
b) Fresh Frozen Plasma, Recall # B-0705-09
CODE 
a) and b) Unit: 53T22279
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , by telephone on May 7, 2008, and follow-up letters dated May 12, 2008 and September 24, 2008. 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 
2 units
DISTRIBUTION 
MD
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0707-09
CODE 
Unit: 29KH50905
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Mid Atlantic Region, Norfolk, VA, by telephone, follow-up letter and e-mail on May 6, 2008. 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 
VA
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II I 
___________________________________ 
PRODUCT 
Source Leukocytes, Recall # B-0619-09
CODE 
Unit: W044607323523
RECALLING FIRM/MANUFACTURER 
Gulf Coast Regional Blood Center , Houston , TX , by facsimile on October 4, 2007. Firm initiated recall is complete.
REASON 
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
CA
___________________________________ 
PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0636-09;
b) Whole Blood Leukocytes Reduced, Recall # B-0637-09;
c) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0638-09;
d) Red Blood Cells, Recall # B-0639-09;
e) Whole Blood, Recall # B-0640-09
CODE 
a) Units: FS16593, GN33635, GN33636, KF36021, KF35957 (Parts 1, 2, & 3);
 
b) Units: GW28881, GW28892, GW28925, KF35955, KF35972, KF36020, LC91583, LJ57816, LJ57834, LJ57836;
 
c) Units: KF35994, GJ04153, GJ04142, KF35994:
 
d) Units: LJ57827, LJ57829, LJ57839;
e) Unit: GJ04141
RECALLING FIRM/MANUFACTURER 
Blood Center of Wisconsin, Inc., Milwaukee , WI , by facsimile on September 20, 2006. Firm initiated recall is complete.
REASON 
Blood products, which were not tested for HIV-1 and HCV by NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
25 units
DISTRIBUTION 
WI, TX, ND, PA
___________________________________ 
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0671-09
CODE 
Unit: 53KY64565 (2 units)
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , by telephone on June 6, 2008, and by letter dated June 11, 2008. Firm initiated recall is complete.
REASON 
Blood products, for which the documentation of the apheresis procedure was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
MD
___________________________________ 
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0673-09
CODE 
Unit: 53LH42794 (2 units)
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore , MD , by telephone on April 29, 2008, and by letter dated April 30, 2008. Firm initiated recall is complete.
REASON 
Blood products, for which the quality control testing for total component hemoglobin was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
MD
___________________________________ 
PRODUCT 
Red Blood Cells (Apheresis), Recall # B-0674-09
CODE 
Unit: Y61396
RECALLING FIRM/MANUFACTURER 
Virginia Blood Services Inc., Richmond , VA , by letter dated February 6, 2008. Firm initiated recall is complete.
REASON 
Blood product, manufactured without the entire quantity of additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
VA
___________________________________ 
PRODUCT 
a) Fresh Frozen Plasma, Recall # B-0679-09;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0680-09
CODE 
a) Unit: Y72754;
b) Unit: Y72754 (Part 1 and 2)
RECALLING FIRM/MANUFACTURER 
Virginia Blood Services Inc., Richmond , VA , by letter dated April 18, 2008. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
3 units
DISTRIBUTION 
VA
___________________________________ 
PRODUCT 
a) Red Blood Cells, Recall # B-0689-09;
b) Recovered Plasma, Recall # B-0690-09
CODE 
a) and b) Unit: 17KW93793
RECALLING FIRM/MANUFACTURER 
The American National Red Cross – North Central Region, Saint Paul, MN, by electronic mail and facsimile on April 14, 2006. Firm initiated recall is complete.
REASON 
Blood products, collected from a donor who had received a tendon transplant within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
MN, IL
___________________________________ 
PRODUCT 
a) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0694-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0695-09
CODE 
a) Units: W087608060672, W087608060742;
b) Units: W087608041151, W087608041533
RECALLING FIRM/MANUFACTURER 
Virginia Blood Services Inc., Richmond , VA , by letter dated June 30, 2008. Firm initiated recall is complete.
REASON 
Blood products, with expired pediatric transfer bags attached, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
4 units
DISTRIBUTION 
VA
___________________________________ 
PRODUCT 
Recovered Plasma, Recall # B-0702-09
CODE 
Unit: 53T13351
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone, letter and e-mail March 21, 2008. 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 
CA
___________________________________ 
PRODUCT 
Recovered Plasma, Recall # B-0706-09
CODE 
Unit: 29KH50905
RECALLING FIRM/MANUFACTURER 
American National Red Cross-Mid Atlantic Region, Norfolk, VA, by telephone, follow-up letter and e-mail on May 6, 2008. 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 
CA
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II 
___________________________________ 
PRODUCT 
Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. The spacer product is intended for consumption during the brachytherapy procedure. Unused (unopened) product is not intended to be inventoried by the attending physician, Recall # Z-1020-2009
CODE 
Lot Numbers: 081009-01, 081009-02, 081009-03, 081023-01, 081023-02, 081106-01, 081106-02, 081106-03, 081113-01, 081113-02, 081113-03, 081113-04, 081113-05, 081118-01 and 081118-02
RECALLING FIRM/MANUFACTURER 
Theragenics Corp., Buford GA , by telephone on December 8, 2008 and letter dated January 13, 2009. Firm initiated recall is ongoing.
REASON 
Some pouches were found to have weak seals potentially compromising sterility.
VOLUME OF PRODUCT IN COMMERCE 
62 units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05 and L-NETC05. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other network devices in Monitor Network. Network connection consists of hardwire network and/or wireless LAN (WLAN) connection. The iCentral can be used for remote monitor management, storage, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other network devices. The Dates-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is to be used by qualified personnel only, Recall # Z-1039-2009
CODE 
Serial Numbers: CZC6261MWB CZC6261MWY CZC5492LK6 CZC61030GL CZC64511LX CZC6482WKP CZC721500G CZC721500H CZC721500J CZC7290DYK CZC7290DYL CZC7290DYT CZC7290DYY 6203582 CZC5521M47 CZC5521M50 CZC7080QKD CZC73312RF CZC73312RP CZC6261MWF CZC7363P37 CZC72414B7 CZC72414BI CZC7250WN8 CZC6103069 CZC6130L3D CZC724149X CZC7272RM7 5225446 6022568 6043180 6065613 6131586 6131596 6203667 6228511 6279463 6307436 CZC5280BRX CZC528244P CZC528244X CZC53003BL CZC5391VF0 CZC5391VG3 CZC5391VGR CZC5472F7W CZC5492LKH CZC5492LKK CZC5510Y67 CZC603076F CZC603076M CZC603076T CZC603076Y CZC61544VJ CZC6181MTL CZC6322Q7G CZC6322Q7W CZC6322Q80 CZC6322Q8C CZC6394DFQ CZC6394DH3 CZC6394DH4 CZC6482WKK CZC6482WKS CZC7414GM8 FRB4210XPW FRB4210XPZ FRB4210XQD FRB4210XQF FRB4210XQG FRB4210XQV FRB4210XQY FRB4210XRD FRB4210XRP FRB4210XSS FRB4210XSX FRB4250QG9 FRB4250QGG FRB4250QGL FRB4250SM7 FRB4250SZR FRB4250T0N FRB4250T0V FRB426012N FRB426013F FRB426014Q 5205328 5170741 5126787 5170740 5170743 6030463 CZC5391VFK CZC5521M48 CZC6228603 CZC64255CB CZC6482WJV CZC7080QJL CZC7080QJZ CZC7364RTP FRB4250QG3 6022570 CZC5492LL9 CZC601030GK 5205326 5205327 5175466 5222754 CZC6394DGP CZC6394DGY CZC7132V7F CZC61030GP CZC6130L35 CZC61544V5 CZC5462BV7 CZC5492LJP CZC5492LKR CZC5492LKX CZC5510Y5Y CZC5521M45 CZC5521M49 CZC5521M4B CZC5521M4C CZC5521M4Y 999999.01 999999.02 999999.03 999999.04 CZC528244V CZC53003BC CZC53003BH CZC53003BJ CZC5521M40 CZC5521M4R CZC5521M4V CZC5521M4X CZC5492LL2 CZC52303S6 CZC52303S8 CZC6181MT7 CZC6261MWS CZC62803TD CZC62803TJ CZC62803TW CZC63128WB CZC63128WN CZC63128WR CZC63128X2 CZC63128X6 CZC6322Q82 CZC6322Q8B CZC6391G9V CZC6394DG0 CZC6394DG1 CZC64006JW CZC64006JZ CZC64006KD CZC64006KX CZC64006KZ CZC64006L2 CZC642558V CZC642558W CZC642559C CZC642559K CZC64255B0 CZC64255B3 CZC64255B5 CZC64255B7 CZC64255BF CZC64255BH CZC64255BM CZC73312RG CZC73312RH CZC73312RL CZC73312S1 CZC7363P2W CZC7363P34 CZC7363P38 CZC7363P3C CZC7363P3G CZC7363P3J CZC7363P3K CZC7364RT6 CZC5391VF3 CZC61030GM CZC6130L2X 5213740 5170753 5182721 CZC5391VGG 5156076 5156077 5156078 5156284 5165853 5205776 5205777 5213727 5213728 5213729 5213730 5213731 5213732 5213733 5213734 FRB4250SZY CZC7414GGD CZC7414GJH CZC6482WKL CZC72414B9 CZC5492LKS CZC63128X5 CZC6482WKM FRB4210XSV FRB4250SM8 CZC6130L3F CZC5510Y64 CZC7250WNJ 6004804 CZC5492LL2 CZC7215010 CZC6394DGV CZC6261MW4 CZC6261MWZ CZC64006KB CZC5240Q16 CZC5240Q18 CZC5240Q1J CZC61030G8 CZC5492LJQ CZC7132V6M CZC7132V83 CZC7290DZ1 CZC5391VF4 CZC6394DFG CZC7364RV6 FRB4210XQ9 FRB4210XQZ FRB4260139 CZC61030GC 6161335 6161447 CZC6261MWT CZC63128WT CZC5510Y6G C2C528245B CZC528245B CZC5492LLM CZC6261MW5 6299938 CZC721500D CZC7272RM2 CZC642559Z CZC5240Q1G CZC6261MWM CZC6322Q88 CZC7272RM6 CZC63128WC CZC5510Y6G CZC5492LK5 CZC5492LLD CZC5492LLH CZC5510Y60 CZC5510Y63 CZC5510Y6B CZC5510Y6J CZC5510Y6M CZC5510Y6N CZC61030GH CZC61030H0 CZC7132V7D CZC7212G4K CZC7212G52 CZC5391VGL CZC5391VDQ CZC6482WKB CZC6482WKY CZC7364RTL CZC7363P2Z CZC7363P3M CZC64006JT CZC64006JY CZC6130L2N 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CZC7250WN6 CZC7250WND CZC7250WNG CZC7250WNH CZC7250WNK CZC7250WNL CZC7272RLV CZC7290DYN CZC7290DYR CZC7290DYZ CZC7363P35 CZC7363P39 CZC7363P3H CZC7364RS3 CZC7364RSB CZC7364RSF CZC7364RV3 CZC7364RVF CZC7414GGF CZC7414GGN CZC6261MWV 5182685 5182686 5175458 CZC6181MSY FRB4250QG4 FRB4250SWY 5199060 5213702 CZC6394DHB CZC6482WJX 5199059 5205778 5205779 5213737 CZC7080QHX CZC7080QJ3 CZC7080QJJ 5182688 5077178 5077179 CZC5282450 CZC5391VF7 6004799 6022584 6048665 C2C5462BV5 CZC5240Q1N CZC5240Q1V CZC5280BRV CZC5280BRY CZC5280BS2 CZC5280BS6 CZC5280BSB CZC5280BSC CZC528244T CZC5282453 CZC528245G CZC528245N CZC530039Y CZC5391VDW CZC5391VFM CZC5391VFP CZC5391VFT CZC5460C7P CZC5460C81 CZC5462BTS CZC5462BTT CZC5462BTW CZC5462BTY CZC5462BVB CZC5462HW4 CZC5462HW7 CZC5462HVX CZC5472F7V CZC5472F81 CZC5472F89 CZC5472F8F CZC5472F8N CZC5492LJN CZC5492LJW CZC5492LK0 CZC5492LKZ FRB4210XQ5 FRB4210XRT FRB4250QGP FRB4250QGX FRB4250T07 FRB4250T0W FRB4250TOL FRB426011K FRB4260138 5175462 5199049 CZC5510Y6Q 5115313 5115312 5123576 5123577 5171816 5171817 5171818 5175460 5213706 5213745 6186143 CZC61030GV CZC6130L2W CZC6181MTK CZC6322Q8D CZC6482WLH CZC6482WLK CZC7105QFC CZC7132V7M CZC724149S CZC724149Z CZC7414GGP CZC5510Y66 5077176 5077177 5182720 CZC5472F7X CZC5472F7Y CZC5472F83 CZC5472F86 CZC5472F8C CZC5472F8H 5100657 5089748 5100629 5225450 5089749 CZC7080QJB 5175439 5175440 5175441 5175443 5175444 CZC5510Y65 5148390 5148391 CZC528244Z FRB4250QGD FRB4250SM9 CZC53003BV CZC5472F7Z CZC61544VW 5205308 5132683 5089742 6228600 CZC5521M4T CZC63128WV CZC6322Q84 CZC64006JD CZC64006JQ CZC64255CC CZC64511L2 CZC64511LR CZC64511LT CZC6482WLN CZC7080QJW CZC7364RSY CZC7364RVH 5225456 6111273 CZC5280BS9 CZC5391VDX CZC5492LJM CZC5510Y6H CZC5510Y6L CZC5521M4S CZC6425591 CZC642559R CZC642559S CZC7132V6N CZC7132V7N FRB4210XRY FRB426012M CZC6322Q7N 5199058 5182691 CZC5492LL4 5140816 5148401 5225428 5156082 5182700 5126772 5199066 5199070 5205303 5205771 5199053 5182719 6120283 6310167 CZC5240Q1K CZC5240Q1R CZC5240Q1S CZC528244Q CZC5282455 CZC5282456 CZC5282457 CZC528245F CZC528245P CZC53003B6 CZC53003BB CZC53003BM CZC53003BN CZC53003BP CZC53003BW CZC5391VDR CZC5391VDZ CZC5391VF6 CZC5391VFL CZC5391VFX CZC5391VGF CZC5460C7W CZC5462HVZ CZC5472F84 CZC5472F85 CZC5492LK1 CZC5492LKY CZC5492LLC CZC5521M43 CZC5521M4H CZC6030771 CZC61030GT CZC6130L2M CZC6130L34 CZC6130L36 CZC61544V8 CZC6181MTR CZC6261MW7 CZC6261MWD CZC6261MWP CZC6261MWX CZC63128WK CZC6322Q87 CZC6394DFT CZC64006JS CZC64006KG CZC64006KK CZC642558X CZC64255BQ CZC64511L3 CZC64511LF CZC64511M2 CZC64511M3 CZC64511M4 CZC7105QDS CZC7212G4F CZC7212G54 CZC7212G55 CZC721500P CZC7244NXH CZC7244NXK CZC7272RLW CZC7290DYD CZC7290DYH CZC7290DYM CZC7290DYQ CZC729ODZ4 CZC73312RS CZC7363P32 CZC7364RVB CZC7364RVG FRB4210XPX FRB4210XQJ FRB4210XQM FRB4210XS2 FRB4210XSH FRB4250SWR FRB4250SZ6 FRB4250SZ7 FRB4250T0Z FRB4260131 FRB426013W FRB426014M 5148402 5148403 5170750 5170758 5170759 5170761 CZC61030G0 CZC61030G5 CZC61030GF CZC5460C7J CZC642559Y CZC642889N CZC7364RRH CZC5472F80 CZC603076R CZC6030777 FRB4250SMB FRB4250SMD 5089747 CZC63128X4 CZC7105QDX CZC7105QFK CZC6391G9T CZC7080QJC CZC7105QFM CZC7363P3F FRB4250T0C 5205305 5156054 5165857 5165856 5199067 6048672 6161298 6279448 6315265 CZC6130L2V CZC61544W0 CZC61544V9 CZC61544VH CZC61544VL CZC61544VQ CZC61544VV CZC61544VY CZC6181MTV CZC6394DFY CZC6394DG4 CZC6394DG8 CZC6394DGH CZC6394DGK CZC6394DH0 CZC6394DH9 CZC64006K9 CZC64006KL CZC64006KR CZC64006KW CZC642558N CZC64511L6 CZC6482WK7 CZC6482WKX CZC6482WL3 CZC6482WLB CZC7105QF0 CZC7132V6T CZC7132V70 CZC7132V73 CZC7132V7K CZC7212G42 CZC73312RQ CZC73312RR CZC73312RW CZC7364RTR CZC7414GGT CZC7414GGZ 5089744 5126786 5213711 5182675 6004814 6049786 6049787 6061486 6061487 6061488 6061489 6061490 6061491 6061492 6095066 CZC5240Q1M CZC5280BS4 CZC5280BSF CZC5280BSM CZC5280BST CZC5282454 CZC5391VDV CZC5441LL0 CZC5462BV6 CZC5492LJV CZC5492LJZ CZC5510Y5W CZC5521M42 CZC5521M46 CZC5521M4P CZC5521M4Q FRB4250QG5 FRB4250QGR FRB4250QGY FRB4250QH3 FRB4250SWV FRB4250SWW FRB4250SZ9 FRB4250SZW FRB4250SZZ FRB4250T02 FRB4250T04 FRB4250T0M FRB426011Q FRB4260129 FRB426013N FRB426013Z FRB4260140 5171825 5199052 5199068 5129985 5175450 5175451 5175452 5182690 5225437 5225438 5100656 5213743 5222753 5205322 5205320 5140815 5156050 6111274 6111275 6228473 6228586 CZC5240Q1C CZC5391VFY CZC5391VG6 CZC5492LKT CZC5492LL6 CZC62803TH CZC7364RS5 FRB426014P 6061496 5089745 5089746 5089743 5205301 5175448 5170762 5170766 5171811 5171812 5182705 5182707 5182708 5182699 5182722 5199041 5199042 5182684 5222765 6004796 6065625 6095050 CZC5391VFQ CZC5391VFV CZC5391VG2 CZC5391VGD CZC5391VGJ CZC5460C7F CZC5460C7N CZC5460C7Q CZC5460C86 CZC5492LJX CZC5492LKC CZC5521M4M CZC5521M4Z CZC6130L2Y CZC6261MWC CZC63128WY CZC6322Q7R CZC64006KS CZC64006KY CZC642558Q CZC642559D CZC64255BW CZC7080QJ7 CZC7364RS9 CZC7414GGV CZC5240Q1D CZC5240Q1H 5182693 5165867 5171809 5165864 5165865 5165866 5205311 5148395 5148397 5205310 5132682 5225447 5148396 5182715 5182716 5182717 5199051 CZC5492LKB CZC5510Y5X CZC5521M4W CZC6181MTH CZC62803TN CZC6394D67 FRB4250SMJ CZC642558M CZC6425592 5182713 5170760 CZC551046P CZC7105QDV CZC7364RTW FRB4210XS1 FRB4250SZN FRB426012P FRB426012T CZC6425594 CZC5280BRW CZC5460C87 CZC5492LKL CZC6394DGG CZC642558P CZC6425597 CZC642559B CZC7080QJ8 CZC7080QK7 CZC603076N CZC61030G6 CZC6322Q7F CZC6322Q7K CZC6322Q7S 5165858 5225425 5213735 CZC7244NXM CZC7244NXQ CZC5472F88 CZC5472F8S CZC53003BK CZC6130L2H CZC6291WTN CZC63128WM CZC64511M0 5225441 CZC72414B3 CZC72414B6 CZC7250WNB CZC7364RRG CZC7364RTK 5175454 5225426 CZC53003B2 CZC53003B5 CZC5492LK4 CZC63128X1 CZC642559F CZC64255B1 CZC7105QF1 CZC724149T FRB4210XSD FRB4250SWZ FRB426011G FRB426013M 5213707 5140807 5156083 5225436 CZC7080QJM CZC7132V7P CZC7414GGC 5156274 5225442 5199047 5199069 5199071 5199072 5182677 5123580 5123581 5123579 5199043 5199044 5089740 5156280 5156273 CZC5280BSS CZC53003B1 CZC5460C7B CZC5462BTZ CZC6130L3C CZC64006L6 CZC642559Q CZC642559T CZC642559W CZC64255B6 CZC64255B9 CZC64255BD CZC64255BL CZC64255BV CZC64255C7 CZC7105QDR FRB4260120 FRB4260124 FRB4260125 FRB426013X CZC61030G4 CZC61030GD CZC61030H2 CZC64255BT CZC64255BY 5100641 5171823 CZC61544VD CZC61544VM CZC61544VZ CZC6261MWH CZC6322Q7Q CZC5240Q13 CZC5240Q14 5165854 5171820 5171821 5171822 5182683 CZC5492LL3 CZC7212G4J 5115306 CZC5460C85 CZC5462HW5 CZC72126A6 5205319 5205772 5205773 5205774 5205775 5170748 5170749 CZC7105QF2 CZC7105QF9 CZC7105QFD CZC7105QFJ 5156055 5156057 5170738 5175464 5175465 5213709 6064621 6064622 6064623 6064624 6064625 6064626 6064627 6064628 6064629 6064630 6064631 6064632 6064633 CZC5521M4K CZC61030GX CZC6130L3G CZC6181MT5 CZC6181MT9 CZC6181MTM CZC62803TC CZC62803TQ CZC62803TT CZC62803V0 CZC63128WD CZC63128WJ CZC63182WL CZC642558L CZC6425595 CZC642559V CZC64255C1 CZC64255CJ CZC64511LQ CZC73312RY CZC7364RRR CZC7364RTQ CZC7364RVD FRB4250SMF FRB4250SMH FRB4250SWS 5148392 5156049 5100633 5140822 5213747 5213746 5170744 5100643 5213749 CZC6383VVK CZC6391G9W CZC6391G9X CZC64006KN CZC64006KT CZC64006KV CZC64006L3 CZC72414B4 CZC7244NXD CZC7244NXP 5065158 5065159 5175445 5175446 5175447 5175449 5065157 5065156 5065152 CZC5280BS5 CZC5280BSK CZC5460C7Y CZC5462HW0 CZC5462HW8 CZC5462HVY CZC5472F8T CZC5492LJS CZC5521M44 CZC6130L2J CZC6130L2L CZC6130L2T CZC63128WF CZC63128WZ CZC63128X7 CZC63128X8 CZC63128XQ CZC64006JH CZC64255BC CZC64255BJ CZC64255C2 CZC64255CD CZC6482WKG CZC7105QDY CZC7105QF8 CZC7105QFB CZC7105QFQ CZC7132V72 CZC7212G50 CZC721500K CZC7244NX4 CZC7244NX8 CZC7244NXC CZC7250WNP CZC7414GHT CZC7364RSH CZC7364RSS CZC7414GGL 5148393 5156278 5156279 5156281 5199076 5199077 5199078 5199079 CZC7080QHY 5077167 5077168 CZC5460C7K CZC7105QFF 5140820 5140821 5175442 5065150 5213703 5156276 5065154 5065155 5225429 5225445 5077174 5140806 5126775 5065151 5199054 5126776 5126779 5182695 5077171 5156052 5156053 5156282 5156285 5225427 5182701 5156275 5170757 5065153 5140819 6120325 6161422 6197653 CZC528245K CZC5391VFC CZC5391VFG CZC5391VFR CZC5391VFW CZC5391VGN CZC5472F8L CZC5492LJY CZC5510Y5T CZC62803T5 CZC62803TL CZC62803TS CZC63128WW CZC6394DH7 CZC64006JK CZC64006JR CZC64006KM CZC642558J CZC6425599 CZC64255CH CZC64511LN CZC64511LS CZC64511M9 CZC7105QDP CZC7105QDT CZC7105QDZ CZC7105QFG CZC7105QFR CZC7105QFS CZC7132V7X CZC7212G4P CZC7212G4Q CZC7244NX5 CZC7244NXF CZC7364RSK CZC7364RSL CZC7364RSV FRB4250QH1 FRB426012S 5165861 5182712 5182714 5182694 5199064 5199065 5148389 CZC6482WJS CZC6482WKF CZC6482WLG CZC6482WLJ CZC7250WNN 5126781 5126782 5126783 5126784 and 5140824
RECALLING FIRM/MANUFACTURER 
Recalling Firm: GE Healthcare, Wauwatosa ,  WI , by letter dated January 26, 2009.
Manufacturer: GE Healthcare Finland Oy, Helsinki , Finland . Firm initiated recall is ongoing.
REASON 
GE Healthcare is providing information about two issues associated with iCentral L-NETO5 and L-NETC05 v4.3, 4.4, 4.5 and 5.0 when used in combination with Dash 2000, 3000, 4000 and 5000; Solar 7000, 8000, 8000M and 8000i; Eagle 3000 and 4000 and ApexPro. The iCentral does not provide audio or visual alarming for the following: A FIB, VT> and PVC(1) alarms when used with ApexPro and VT>2 and PVC (1) when used when used with Solar, DASH or Eagle (Cardiac Package software). The concern is that this issue may lead to delay in treatment.
VOLUME OF PRODUCT IN COMMERCE 
2,146 units
DISTRIBUTION 
Nationwide and countries of Australia, Austria, Barbados, Belgium, Bolivia, Brasil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Gayana, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libyan Arab Jamahiriya, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russia Federation, Saudi Arabia, Singapore, Slovak IA, South Africa, Sloven IA, South Korea, Spain, Sweden, Switzerland, Syria Arab Republic, Thailand, Tunas IA, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Yemen
___________________________________ 
PRODUCT 
a) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile; REF 32-8105-027-04. The device is utilized for a total elbow arthroplasty surgical procedure, Recall # Z-1053-2009;
 
b) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 6 inch length, sterile; REF 32-8105-027-06. The device is utilized for a total elbow arthroplasty surgical procedure. Recall # Z-1054-2009;
 
c) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, 3 inch length, sterile; REF 32-8105-043-01. The device is utilized for a total elbow arthroplasty surgical procedure, Recall # Z-1055-2009;
 
d) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, 3 inch length, sterile; REF 32-8105-043-02. The device is utilized for a total elbow arthroplasty surgical procedure, Recall # Z-1056-2009;
 
e) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, long, sterile; REF 32-8105-093-01. The device is utilized for a total elbow arthroplasty surgical procedure, Recall # Z-1057-2009;
 
f) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, long, sterile; REF 32-8105-093-02. The device is utilized for a total elbow arthroplasty surgical procedure, Recall # Z-1058-2009
CODE 
All lots
RECALLING FIRM/MANUFACTURER 
Zimmer, Inc., Warsaw , IN , by letter dated January 30, 2009. Firm initiated recall is ongoing.
REASON 
The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.
VOLUME OF PRODUCT IN COMMERCE 
14,613 units
DISTRIBUTION 
Nationwide and countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Jordan, Latin America, Netherlands, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey and Venezuela.
___________________________________ 
PRODUCT 
Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use device intended for pressed fit reconstruction of the femoral portion of severely disable and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic, arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present. a) Part Number SC1439-0600; b) Part number SC1439-0700; c) Part number SC1439-0800; d) Part number SC1439-0900; e) Part number SC1439-1000; f) Part number SC1439-1125; g) Part number SC1439-1250; h) Part number SC1439-1375; i) Part number SC1439; j) Part number SC1439-1625; k) Part number SC1439-1750, Recall # Z-1073-2009
CODE 
a) Lot numbers 8257-062904, 14298-0922705, 1740-091007, 14298-092705, 2256-110299, 4844-010302, 5447-072902, 6790-070803, and 8257-062904; b) Lot numbers 8258-062904, 16935-103006, 17874-061307, 1883-091007, 10559-040105, 16298-042606, 16935-103006, 2257-031199, 4845-101801, 6573-060303, 10559-040105, and 16935-103006; c) Lot numbers 19636-103006, 17875-043007, 19889-060208, 15910-013006, 16936-103006, 17875-043007, 4048-020701, 4418-071901, 5973-091202, 9776-102704, and 16936-103006; d) Lot numbers 16937-092506, 16301-042606, 16937-092506, 17876-071707, 10560-040105, 16301-042606, 16937-092506, 3201-110399, 3791-092000, 4617-102401, 6791-070803, 8487-071204, 14989-101205, and 16937-092506; e) Lot numbers 17610-032207, 14990-101005, 16166-050906, 16166-052206, 16306-082106, 17610-032207, 5260-062702, 7340-011204, and 16306-082106; f) Lot numbers 16938-092906, 17729-031907, 19152-042908, 20652-101308, 14991-091405, 15913-011806, 16439-050406, 16938-092906, 17729-031907, 2261-110299, 6113-111102, 6177-010703, 7341-090203, 15913-011806, and 17729-031907; g) Lot numbers 16839-082106, 8003-052504, 16939-102306, 17730-031907, 10563-040505, 15911-013006, 16839-082106, 16939-102306, 4420-1000901, 5006-040402, 6793-060303, 8003-052504, 16839-082106, and 16939-102306; h) Lot numbers 17731-031907, 17731-031907, 20654-092208, 10172-120604, 10564-041205, 14993-092605, 15912-013006, 17731-031907, 3794-121300, 15912-013006, and 17731-031907; i) Lot numbers 8025-052504, 19153-042908, 14299-092705, 1889-110299, 19153-042908, 5262-050202, 6306-021803, 8025-052504, 5262-050202, and 8025-052504; j) Lot numbers 1749-110299, 17120-022707, 1749-032007, 1749-110299, 2265-091499, 17120-022707, and 1749-110299; k) Lot numbers 1750-110299, 1169-091007, 1169-120406, 1649-030707, 1649-081307, 1649-091007, 1750-091007, and 1750-110299
RECALLING FIRM/MANUFACTURER 
Stelkast Co., Memurray , PA , by telephone on October 31, 2008. Firm initiated recall is ongoing.
REASON 
A possible breach of the sterile barrier packaging (Tyvek pouch).
VOLUME OF PRODUCT IN COMMERCE 
187 units
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. Semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RPN (Ro), SSB(La) and Scl-70 in human sera. This device is for in-vitro diagnostic use, Recall # Z-1089-2009
CODE 
Lot number: 08041819, Exp. 11/2009; Lot number: 08041811, Exp. 11/2009
RECALLING FIRM/MANUFACTURER 
Zeus Scientific, Inc., Somerville , NJ , by letters on August 19, 2008. Firm initiated recall is ongoing.
REASON 
The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266.
VOLUME OF PRODUCT IN COMMERCE 
33 units/lot # 08041819; 27 units/lot # 08041811
DISTRIBUTION 
Nationwide
___________________________________ 
PRODUCT 
ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K, Recall # Z-1122-2009
CODE 
Serial numbers: 100268621 to 100717475
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Trumpf Medical Systems, Inc., Charleston , SC , by letter starting February 27, 2009.
Manufacturer: Trumpf Kreuzer, Puchheim , Germany . Firm initiated recall is ongoing.
REASON 
Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area.
VOLUME OF PRODUCT IN COMMERCE 
4,480 units
DISTRIBUTION 
Nationwide and Internationally
___________________________________ 
PRODUCT 
a) Stryker Electric Stretcher with the Quick Drop CPR option, Model 1050, Recall # Z-1230-2009;
 
b) Stryker Electric Stretcher with the Quick Drop CPR option, Model 1550, Recall # Z-1231-2009
CODE 
a) Serial numbers 94113214, 94113215, 94113216, 94113217, 94113218, 94113219, 94113220, 94113221, 94113222, 94113223, 94113224, 94113225, 94113226, 94113227, 94113228, 94113229, 94113230, 94113231, 94113232, 94113233, 94113234, 94083551, 94083552, 94083553, 94083554, 94083555, 94083556, 94083557 A, 94083558, 94113211, 9501031208, 9501031209, 9501031210, 9501031211, 9503032237, 9503032238, 9503032239, and 9503032240;
 
b) Serial numbers 93064826, 93094750, 93094765, 94023751, 94023753, 94023754, 94023755, 94023756, 94023757, 94023758, 94023759, 94023760, 94033751, 94033752, 94033753, 94033754, 94033759, 94043251, 94043252, 94043253, 94043254, 94043261, 94043262, 94043263, 94043264, 94043265, 94043266, 94043267, 94043268, 94043269, 94043270, 94043271, 94043272, 94043273, 94043274, 94043275, 94043276, 94043280, 94043281, 94043282, 94043283, 94043284, 94053651, 94053652, 94053653, 94053654, 94053659, 94053660, 94053684, 94053685, 94063501, 94063502, 94063503, 94063504, 94063505, 94063506, 94063507, 94063508, 94063509, 94063510, 94063511, 94063512, 94063513, 94063514, 94063515, 94063516, 94063517, 94063518, 94063519, 94063520, 94063521, 94063522, 94063523, 94063524, 94063525, 94063526, 94063527, 94063528, 94063529, 94063530, 94063531, 94063532, 94063533, 94063534, 94063535, 94073201, 94073202, 94073203, 94073204, 94073205, 94073206, 94073207, 94073208, 94073209, 94073210, 94073211, 94073212, 94073213, 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RECALLING FIRM/MANUFACTURER 
Stryker Medical Div. of Stryker Corp., Portage , MI , by letter dated February 27, 2009. Firm initiated recall is ongoing.
REASON 
The head section backrest (fowler) may not raise up, or , if up, may drop suddenly due to wearing out of the actuator threads on the fowler.
VOLUME OF PRODUCT IN COMMERCE 
3,645 units
DISTRIBUTION 
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III 
___________________________________ 
PRODUCT 
BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and other quality control measures for growth media. Certified to deliver less than 100 organisms per dose, Recall # Z-1043-2009
CODE 
Lot number: 121208, Expiration Date: 2-12-09
RECALLING FIRM/MANUFACTURER 
Lexamed, Toledo , OH , by telephone on January 13, 2009 and letter on January 14, 2009. Firm initiated recall is ongoing.
REASON 
Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution.
VOLUME OF PRODUCT IN COMMERCE 
1 vial
DISTRIBUTION 
UT
___________________________________ 
PRODUCT 
RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system; Kit catalog number: 7096-09 and kit catalog number: 7696-09, Recall # Z-1045-2009
CODE 
Lot number: 0821407 and lot number: 0821404
RECALLING FIRM/MANUFACTURER 
Immuno Concepts, Inc., Sacramento , CA , by telephone, e-mails and letters on December 1l, 2008. Firm initiated recall is ongoing.
REASON 
In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.
VOLUME OF PRODUCT IN COMMERCE 
25 kits
DISTRIBUTION 
Nationwide, Australia , England , Sweden and Austria

END OF ENFORCEMENT REPORT FOR APRIL 8, 2009 
 
 

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