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U.S. Department of Health and Human Services

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Enforcement Report for January 28, 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.

January 28, 2009
09-04

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

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PRODUCT 
a) Lund's Swedish Pancake Mix, Net wt. 12 oz. box, 12 boxes per case; UPC 41631-00055, Recall # F-076-9;

b) Lund's Gourment Waffle Mix, Net wt. 12 oz. box, 12 boxes per case; UPC 41631-00058. Recall # F-077-9
CODE
All lots within expiration date. Expiration dates are imprinted on the bottom of the box as month/year, i.e. 06/10 for June 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Noon Hour Food Products, Inc., Chicago IL, by telephone on December 24, 2008 and by e-mails and letter on January 6, 2009. 
Manufacturer: Profile Food Ingredients, Elgin, IL. Firm initiated recall is ongoing.
REASON
The product lists whey powder as an ingredient but does not list milk as the source of the whey as required by FALCPA (Food Allergen Labeling and Consumer Protection Act).
VOLUME OF PRODUCT IN COMMERCE
29,676 cases
DISTRIBUTION
Nationwide
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PRODUCT 
Nestl Farinha Lactea cereal product in 400g canisters with UPC Number: 7891000252604. The labeling on the canisters indicate that the product is manufactured by Nestl in Brazil. The product is packaged 24 canister units per case. Case UPC is 17891000025212. Recall# # F-078-9
CODE
Lot Numbers: 733912281, 811312281, 813812281, 817012281, 817512281, 817912281, 811412281, 817912281, 820212281, 820312281, 825912281, 827412281 Note: All codes are being removed.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nestle USA, Glendale, CA, by press release and e-mail on November 3, 2008.
Manufacturer: Nestle Brasil Ltda. , Sao Jose do Rio Pardo , Brazil. Firm initiated recall is ongoing.
REASON
Product contained an unapproved pesticide residue (pirimiphos methyl) based on the Connecticut Agricultural Experiment Station's and FDA's analysis. Additionally, the label did not list ingredients in English.
VOLUME OF PRODUCT IN COMMERCE
2,.680 cases (24 units per case)
DISTRIBUTION
Nationwide to wholesalers in FL and NJ

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

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PRODUCT 
PrednisoLONE Syrup (PrednisoLONE Oral Solution USP), 15 mg/5 mL, a) Unit Dose Packs, NDC 0121-0687-05; b) 8 oz, NDC 0121-0687-08; and c) 16 oz bottles, NDC 0121-0687-08. Rx Only. Recall # D-169-2009
CODE
a) Lot numbers: 7B20, 7E39, 7G40, 7J05, 7K36, 8A12, 8B03, 8B08, 8B67, 8C75;
b) Lot numbers: 7B22, 7D36, 7E38, 7G39, 7J03, 7K34, 7L32, 8B09, 8B65;
c) Lot numbers: 7B21, 7E37, 7G38, 7J04, 7K35, 8B10, 8B66, and 8C74
RECALLING FIRM/MANUFACTURER
Pharmaceutical Associates, Inc., Greenville, SC, by letters on August 4, 2008.Firm initiated recall is ongoing.
REASON
Exceeds Impurity Specification.
VOLUME OF PRODUCT IN COMMERCE
46,411 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

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PRODUCT 
a) Goldline Genasyme Drops, Simethicone Oral Suspension, USP, Simethicone 40 mg per 0.6 mL, 1 fl oz (30 mL), D-167-2009;

b) Rugby Gas Relief Drops, Simethicone Oral Suspension, USP, Simethicone 20 mg per 0.3 mL, 1 fl oz (30 mL), Recall # D-168-2009
CODE
a) Lot #’s: FBD002, FBD001, and EBD005;
b) Lot #: EBD006
RECALLING FIRM/MANUFACTURER
ANIP Acquisition Co., Gulfport, MS, by letter on July 31, 2008. Firm initiated recall is ongoing.
REASON
Miscalibrated delivery system; There may be incorrect dosage markings on medicine dropper which could result in subpotent dose.
VOLUME OF PRODUCT IN COMMERCE
109,608 units
DISTRIBUTION
PA, NY
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PRODUCT 
CARBOplatin for Injection USP, single-dose vial, 450 mg per vial, Rx only, NDC 50111-967-76. Recall # D-172-2009
CODE
Lots: 23001907A, exp. 2/09; 23019607A, exp. 11/09 and 23002208A, Exp. 01/10.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Barr Laboratories, Northvale, NJ, by letters on December 8, 2008.
Manufacturer: PLIVA-Lachema a.s., Brno, Czech Republic. Firm initiated recall is ongoing.
REASON
Discoloration: slight gray discoloration caused by the presence of elemental platinum, which is also contained within the Carboplatin molecule.
VOLUME OF PRODUCT IN COMMERCE
12,850 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT 
Platelets, Recall # B-0282-09
CODE
Unit: 7950264
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on August 21, 2007 and by letter on September 12, 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
TX
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PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0354-09
CODE
Unit: 027GW30654
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone and email on July 29, 2008 and by follow-up letter on July 30, 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
WV
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PRODUCT 
Source Plasma, Recall # B-0377-09
CODE
Units: 363016138, 363016408, 363016950, 363017201, 363017711, 363018249, 363018667, 363018975, 363019374, 363019716, 363021115, 363021459, 363020357, 363020746, 363021670, 363021970, 363022839, 363023175, 363028486, 363028681, 363029547, 363030066, 363030604
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Fort Worth, TX, by fax on June 22, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
NC
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PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0378-09
CODE
Unit: W071208005020
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on May 7, 2008 and by follow-up letter on May 8, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced, but which had not undergone leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
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PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0379-09
CODE
Unit: W036208187080
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on August 7, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who tested repeat reactive for STS (Serum test for Syphlis) with a positive confirmatory result, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
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PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0394-09;
b) Platelets, Recall # B-0395-09
CODE
a) and b) Unit: 9569532
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on July 23, 2008 and by letter on July 29, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, MI
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PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0396-09
CODE
Unit: 4045710
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and letter on June 12, 2008. 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
TX
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PRODUCT 
a) Red Blood Cells Leukocytes Reduced, Recall # B-0399-09;
b) Cryoprecipitated AHF, Recall # B-0400-09
CODE
a) and b) Unit: 6649661
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on May 16, 2008 and by letter on May 22, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
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PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0407-09  
CODE
Units: 16KK23799 (split product)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Columbus, OH, by letters dated July 19, 2007 and August 20, 2007. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
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PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0408-09
CODE
Units: 7725279; 7724935
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by telephone on October 17, 2005. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
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PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0411-09
CODE
Unit: 026KG0809
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone or electronic notification on March 8, 2007 and by letter dated March 21, 2007.
Manufacturer: American Red Cross Blood Services, Montgomery, AL. 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
AL
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PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0413-09
CODE
Unit: 041LX50807
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone or electronic notification and by letter dated March 19, 2007.
Manufacturer: American Red Cross Blood Services, Alabama Region, Huntsville, AL. 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
AL
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PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0415-09
CODE
Unit: 026FK65286
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone or electronic notification on April 19, 2007 and by letter dated April 26, 2007.
Manufacturer: The American National Red Cross, Mobile, AL. 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
AL
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PRODUCT 
Blood Cells Leukocytes Reduced, Recall # B-0418-09
CODE
Units: 019GV27116; 019LJ29154
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by letter and electronic mail on September 19, 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
2 units
DISTRIBUTION
TN
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PRODUCT 
a) Platelets Leukocytes Reduced Irradiated, Recall # B-0420-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0421-09;
c) Fresh Frozen Plasma, Recall # B-0422-09
CODE
a), b), and c) Unit: 19LT35959
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by fax and letter beginning on October 18, 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
TN, KY
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PRODUCT 
a) Red Blood Cells, Recall # B-0426-09;
b) Platelets, Recall # B-0427-09
CODE
a) and b) Unit: 8801052
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by telephone and fax on September 8, 2006. 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
FL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT 
Recovered Plasma, Recall # B-0355-09
CODE
Unit: 027GW30654
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone and email on July 29, 2008 and by follow-up letter on July 30, 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

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PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0397-09
CODE
Unit: 125946250
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 27, 2008 and by letter on June 11, 2008.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM
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PRODUCT 
Recovered Plasma, Recall # B-0398-09
CODE
Unit: 6649661
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on May 16, 2008 and by letter on May 22, 2008. 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
Switzerland
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PRODUCT 
Source Plasma, Recall # B-0409-09
CODE
Unit: KZ038995
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by fax on March 27, 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
Austria
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PRODUCT 
Source Plasma, Recall # B-0410-09
CODE
Unit: KP110533
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by fax on April 15, 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
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PRODUCT 
Recovered Plasma, Recall # B-0412-09
CODE
Unit: 026KG0809
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone or electronic notification on March 8, 2007 and by letter dated March 21, 2007.
Manufacturer: American Red Cross Blood Services, Montgomery, AL. 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
CA
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PRODUCT 
Recovered Plasma, Recall # B-0414-09
CODE
Unit: 041LX50807
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone or electronic notification and by letter dated March 19, 2007.
Manufacturer: American Red Cross Blood Services, Alabama Region, Huntsville, AL. 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
CA
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PRODUCT 
Recovered Plasma, Recall # B-0416-09
CODE
Unit: 026FK65286
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by telephone or electronic notification on April 19, 2007 and by letter dated April 26, 2007.
Manufacturer: The American National Red Cross, Mobile, AL. 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
CA
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-0417-09
CODE
Units: 019GV27116; 019LJ29154
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by letter and electronic mail on September 19, 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
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0433-09
CODE
Unit: GW27794
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on August 21, 2006. Firm initiated recall is complete.
REASON
Blood product, which may have reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
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PRODUCT 
NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis. Recall # Z-0001-2009
CODE
Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002 and NDHR080003
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, North America Co. Phillips, Bothell, WA, by letter during June 2008.
Manufacturer: Philips and Neusoft Medical Systems Co., Ltd, Shenyang, Liaoning, China. Firm initiated recall is ongoing.
REASON
An issue associated with the “Timed Scan” application was found. The system does not wait for the programmed time interval and starts the x-ray after selection of the scan button when certain criteria is met.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide
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PRODUCT 
a) GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System. The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-0473-2009;

b) GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System. The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-0474-2009;

c) GE Innova 4100 /4100 IQ. , The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. Recall # Z-0475-2009
CODE
a) 505848CATH1 505848EP 318448INNOVA3 305682IN2 4105502100 410554INNOVA2 208367INNOVA 208381CCL1 2035762100 717217CA10002 843797TCL1 214947MINNOVA 214947MINNOVA2 PRESBYDEP 303839CL2 252384CATH1 303788CL1 4436432100 4107872100 8184092100 864255SFCL2 219932DCL2 305364P2100 954987CL4 713794LAB1 727869CATH3 727869CCL2 727869EP5 208227CATH1 8157412100 816861KCVAI2 308865GIN1 865693CCL 865693CCL2 608775NOVA2 0002507622 310825INNOVA21 516562INNOVA6 516562INNOVA7 865977CCL 217383CCL2A 541732CV2 0002698287 0002698301 251435ICV3 239436CATH4 732776CATH4 212305CATH1 212604INNOVA1 65049321 304424INNOVA 610983INNOVA2 201447LAB1 215453INNOVA21 253627INNOVA1 229228INNOV21C 8053702100 RPINNOVA2100 303425CL3 305682IN2X 317355INNOVA3 318448CA1000 330363LAB3 330375LAB2 336538ARCL1 360456XCL4 405604D2100 408559INV1 410554INNOVA1 414291CL2 414649INNOVA2 417269SCLA 417347FCV4 423495MCATH1 501257VALAB1 508335CA1 508856IN21 509575YM2100 516562INNOVA2A 518243LAB1 518243LAB2 561548ET2 570476INNOVA21 573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 607737CL1 608775NOVA1 610250INNOVA1 610250INNOVA3 610776INNOVA21 612273INNOVA2 615284CV3 615342CV3 615446CV1 617636CL1 630856H2100 650369SV4 651582IN3 661327INNOVA1 661327INNOVA2 706291CLIN1 713375U2100 713375UCA 717217INN21 717544GECATH2 717544GECATH3 718470EP 718780CATH3 727942CATH2 732324INN1 732923INN 770HMCCL1 781340IN1 781340IN3 785354HRTEP 803256PCL5 808547QCV1A 808547QCV3A 812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 814452EP 815741CA1000 815759CARDIAC1 817329BG2100 843724CL1 843724CL2 843724CL3 843724EP1 845368LAB1 845368LAB2 856853IN2100 858554INNOVA2 858554INNOVA3 864255SFCL1 904597CATH 910343EP1 910343EP2 910671INOV21 916781INNOVA2 937208INNOVA2 954735CL2 954987CCL7 954987CCL8 970350CL2 9704CHINNOVA 973579LAB1 985898INNOVAA 985898INNOVAB CM2100 ECXV1406F FHOMEP 508941IN21 508335INNOVA 843692CATH3 828213IN21 901765EP 410554INNOVA4 410554INNOVA3 251435ICV7 262255INNOVA2 303369HCL4 410337INNOVA6 573256MHC 804764CATH2 845365V13 7023602100 9284532100 336832MCCL6 402559UCD 775982INN2100 847316INNOVA1 847316INNOVA2 LVINOV7 0910162009 0910162010 0910162011 0910162012 0910163011 0910163014 0910162013 010120RX44 0002673668 2673668/0002673668 082416100014 082416150002 082416100011 082416130026 082416010005 082416010007 082416030005 082416040011 082416040012 082416040014 082416050003 082416060001 082416070006 082416100009 082416100012 082416100017 082416120008 082416130016 082416130019 082416130023 082416130024 082416160007 082416180003 082416200004 082416210007 082416220010 082416120009 82416030004 82416100007 82416140006 082416ATCINNOVA 82416110005 82449150034 604875AINNOVA1 416480INNOVA 604682INNOVA1 604682INNOVA2 604875AINNOVA2 416864INNOVA 468668XR01 26814ANGI2 2664023INNOVA CS1118VA03 CS1006VA04 HC4348XR02 PC0052XR07 PC0052XR08 507902XR01 HC0222XR35 HC4355XR06 HC4480XR05 DK1066VA02 DZ1006VA01 FEB52055 ME612436 CEE15663 FI1017VA02 FI1017VA03 FI1025VA01 A4166952 B1650215 B5483438 M1334109 M2068110 M2569315 M2844529 M4176519 M4183841 M4200108 M4211066 M4496941 B4192944 M2621511 M4198195 M181374801 00060VAS02 00159VAS04 00192VAS04 00192VAS05 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03 00463VAS06 00888VAS02 01065VAS01 05208VAS02 05217VAS02 05451VAS01 10507VAS01 00197VAS01 10086VAS04 H2077VAS27 H17654VAS8 H0002VAS66 0828160007 600010VA01 HU1094VA01 HU1116VA01 HU1205VA01 HU1231VA10 HU1099VA02 0835160017 0835160018 835160021 IE1100VA02 0002644132 08301600206936 083016002101586 083016102100795 083016202101036 083016202101917 083016242100936 083016282101457 083016602101386 083016802100516 083016802100866 083016802100916 083016862101407 083016862101656 083016862101916 83016802100337 83016862100377 083016602101807 083016802101197 083016822101187 8.30168E+12 8.30162E+13 2673438 8.30161E+13 A5333036 A5333037 A147111802 A5125125 A5129025 A5131858 A5155141 A5164510 A5219606 A5220710 A5286803 A5400910 A5605743 A5624112 A5800506 A5807919 A58080104 B5120723 B5219603 C5123625 C5123626 C5323515 A5624127 A5697709 A5764002 B5603933 YV0053 YV0054 YV0057 YV0058 YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066 YV0067 YV0068 YV0069 YV0070 YV0071 YV0072 YV0073 YV0074 YV0075 YV0076 YV0077 YV0078 YV0079 YV0080 YV0081 YV0100 YV0055 YV0056 YX1483 YV0082 0850060723 KW1018VA05 KW1018VA01 KW1018VA02 KW1018VA03 LT4000VA04 LV4000VA02 LV4000VA03 LV4001VA02 MA1004VA02 0002679402 0002684003X 644INNOVA21 83INNOVA2588441 NO1009VA03 NO1064VA03 920169006 600151VA01 600042VA03 0002674834 787844INNOVACL1 787844INNOVACL2 787844INNOVACL3 PER00218 SA1011VA01 SA1054VA02 SD1038VA01 A004RX01 A020RX13 0847160002 0847160003 2682877 SK1110VA01 SY1001VA02 SY2005VA01 06052VAS01 20001VAS02 34009VAS06 34134VAS02 35049VAS01 58010VAS01 80002VAS01 06004VAS03 35021VAS02 0853060191 853060197, and 853060193;

b) 215576INNOVA1 760242CATH1 404686CRI3 281420LAB23100 541382CV3 205783BCL5 2035763100 508941IN1 843797TCL2 361980INNOVA2 214590PH3100 303629CL4 303629EP 3027443100 7018573100 303788CL2 239939CLA 850862IN3100 352333CATH1 352333CATH2 8184093100 919731WMINOV 305364P3100 205877CCL1 281440CL3 208227CATH2 2014183100 7028533100 865693CCL1 609757IN3100 6619483100 219326IN31 7022333100 816969LSCATH 209334LINNOVA1 310319SM3100 502587LAB1 219877IN31 9734293100 215335INNOVA1 239436CATH3 239513CRLAB1 8053703100 615222H 812858GWLAB1 812858GWLAB2 8014793100 270688INN 65049331 850747BR3100 6106483100 8508573100 850469BCV1 207662CL4 207879CL131 951788INNOVA3 951788INNOVA2 541677MINNOVA1 5033703100 253968INNOVA 254742KDCL1 662377CV4 412437INNOVA 9202623100 303425CL4 2197573100 0002595303 228818VASC 316651INNOVA31 316962WCVC1 316962WCVC2 325428CATH1 325428CATH3 336832MCPV 360456XCL3 361857CATH1 405272SCL2 405372S3100 405604D3100 405840OIC3100 406447VAIN3 406543IN3 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 502852INNOVA 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 516663INNOVA1A 530244XC106 561548CL4 570476INNOVA31 573458CL1 573632CRC2 6012883100CV2 603421PCL 610595CL1 610770INNOVA31 610983INNOVA1 616392INNOVA 617732IN9 618241GSI3100 620225INNOVA31 631968INNOVA2 631968INNOVA3 662377CV2 671GMHAINVA 708WESTSUB3100 713359INC 713948INA 717782INNOVA31A 718245UNITY 718470INNOVA2 718780CATH2 732776CATH6 770991CL1 772LWCL1 775982CATH2 781340IN2 803255CL1 804285CATH1 814676C1 815344CARDIAC3 815756KCHSPEC 816478MC1 816861KCVAI1 816943STJIC1 816985NKCI 847362CONCATH4 856596IN3100 864255SFCL3 901516R3 903UT3100 904276CTH1 909464IN3 909825VAINNOVA 910343NHIN4 913345MI1 940626DCH3100 954987CCL9 956698INN31 970350CL1 970945CL1 973877LAB4 ECXV1406B FHORLCL7 580548B3100 941798CLAB2 760323DRINNOVA 718270INNOVA1 603580ECL1 410740CV MARTINSVILLE310 480728LAB2 865481CCL2 405610NW3100 8157413100 251633PROV 907562CATH1 919784REP1 601883CL1 650369SV3 610954INNOVA1 760242CATH2 314768SMCL1A 2035763100A 402559UCB 561694IN1 2036883100 201996LAB1 205877CCL2 207351YCL1 251435ICV6 281420LAB1 314525STACL2 334418CL 412623LAB2 479441SP3100 480821IN2 508856IN2 541MWHINNOVA 573882UMC1 610447CL1 610526LAB1 610526LAB2 610891CL1 617789IN1 631376EP 704384CATH2 706481CCL 706774CCL4 706774CCL5 713776M3100 717782INNOVA31 803256PCL1 812450CATH1 815226INN2 863687CL31 916781INNOVA1 918494IN31A 952993INNOVA5 BPINNOVA1 845365V19 918333JPIN1 909788INNOVA1 516663INNOVA2 2652143 8185023100 0002686429X 312STMNAZ3100 630312B31 717782INNOVA31B 727725CATH2 785354S3100 918333JPIN2 378INV31 0910064009 0910163012 0910163013 0910163015 910064007 910064008 910162006 910162008 910163006 910163007 910163009 BA4080VA01 140024RX09 BG4549VA02 2573329 2667313 2676587 BE5003VA02 082416040018 082416140004 082416290001 082416140003 082416130018 082416080001 082416010006 082416020004 082416020005 082416030006 082416040015 082416040019 082416100013 082416110002 082416110003 082416120010 082416140002 082416150001 082416160008 082416160009 082416160013 082416180004 082416190004 082416190001 082416190002 082416190003 082416210006 082416210008 082416220008 082416270002 082416300001 082416310003 082416310006 082449100050 082416160011 082416170002 82416030003 82416030008 82416030010 82416100006 82416100010 82416100019 82416120007 82416120011 82416130015 82416160003 82416160006 82416210003 82416210004 82416310007 082416220009 82416130017 82416030009 82416120012 82416180005 82416310008 2625365INNOVA 2645993INNOVA CS1006VA03 HC4348XR01 0002655786 MPX82206 FPG86403 FPG93008 DPM32143 DPN88402 FPA99414 FI1064VA01 M2030709 M4163030 M4166988 M5480755 M6083613 A6017504 M2848425 M2970614 M4016034 M40480151 A9190149 M40480167 00203VAS01 01367VAS02 GE1005VA01 HU1099VA04 A5127281 A5112597 A5162256 A5333035 A5812244 B5274834 B5332001 B5810907 A5125119 JO1000VA01 YV0162 YV0048 YV0163 XF0250 YV0033 YV0034 YV0035 YV0038 YV0039 YV0040 YV0042 YV0043 YV0044 YV0045 YV0046 YV0047 YV0049 YV0050 YV0051 YV0023 YV0024 YV0025 YV0027 YV0028 YV0029 YV0030 YV0031 YV0032 YV0037 0850060719 0850060724 0850060726 0850060727 0850060728 KW1055VA01 52XVINN2565367 818INNOVAHM2 477XVIN2553211 0834160003 NO1005VA05 0920169007 2048000INNOVA 2664627INNOVA 2685467INNOVA PL1082VA01 600098VA01 RU1482VA02 RU1475VA01 RU1142VA01 RU2581VA01 SA1010VA02 01012VAS01 41018VAS01 58002VAS01 60001VAS01 34268VAS01 0853060194, and 388567772VASMET;

c) "0002651236A 813745INTV" 0002701957A 3184734100 706774USP3 6309784100 6616324100 304256INNOVA 2035764100 352596SPEC 423495MSPEC2 5135844100 719560INN41 303320OR41 303399IR 303436ANGIO 3027444100 574294IN41 239939INNOVA 252847PRS3 864255SF4100 305823IN4100 7137764100 3016094100 414649CL2 812858GWSP 212639ACT1 8014794100 304424CCINOVA 309655FSP1A 4134474100 5033704100 509474SH41 201541SP1 281401T4100 918744JR4100 22925941V2 586573SP1 SHOWCASE4100 314569SJRM12 314966DPHSP 317887INNOVAPV 330489SPEC9 352333INVOR 386254HS1 386254HS2 386HPOS1 404466SF41A 404GHSIR1 410337INNOVA2 412647OR10 414649DVI 419696LAB1 505848CATH2 505848V4100 508650IN41 509482HFI 512901NI4100 530888ANG206 541686SPR1 561548VAS2 570321LAB2 605333RM10 610988INNOVA4 617636IN1 619229INNOVA1 623848SP 630275G41 630275G41B 650493ANGIOCT 662244GTSP 678EJCIR1 706291RINN2 706651SP1 706733SP1 708783CL4100 708783SP4100 713375U4100 718630LIBERTY 727791INNOVA 770535N4100 803256SP 804594ANGIO 812238UN41 812825INNOVA1 813615CL10 815740SC4100 817465AR4100 817922BA4100 843577CL2 845368RM10 850747IN4100 863687INV24 864573LAB2 865373SP 865481SUR 908522SP1 915577SP1 918682IN41 954MW4100 970247INNOVA COR359867 DR4100 FHORL4100 PEMBROKE4100 RADNETXV1 RHD4100 480512SP 8458584100 770736SP1 423495M4100E 423493I4100 8593134100 313343SP1 708202VA41 708WESTSUB4100 509575YM4100 80140841 80180741 2194654100 4082594100 4105434100 4137484100 5094744100 5417684100 5703214100 5705224100 6082634100 7023604100 7028804100 219326IN41 229228INNOV41C 22925941V 251435I12 252816INNOVA 269226IN1 269226IN2 269983IN41 303839CL1 308534ANG 309672M4100 312792R4100 313876SP41 316651INNOVA41 317338PV3 360754INNOVA 401274IN41 412623LAB1 412623LAB3 414328INN4100 419251LAB1 508383IN4100 512528CPCL1 541282CV2 603650ANG1 608263ACT 608263XMR 608324DAL 610954INNOVA41 617525IN1 617726RF2Y6 626359INNOVA 650369SV5 706291RINN 718206LIBERTY1 760633IR1 773878SWGANGIO1 801268INNOVA 804285CATH2 804764CATH3 810342A41 813558INTV 816943SP1 817433HSW4100 828298VASC 847842GS4100 856365ANGIO 903GS4100 904202SP1 904BSSP 913317SLS4100 952993INNOVA2 972335LIB 972487ANGIO1 972566INNOVA3 985867INNOVA2 ECXV1406E MIRAMAR41 WCATHLAB41 334286BSP 757889INNOVA 706278INNOVA1 561747IN4 252847PRS2 918744JC4100 5136864100 850494WSP1 FWANG3217 0002520549AX 252816INNOVA 309343CSP1A 309655FSP3A 802295VALCA 190020RX09 082406070010 082406310005 082416030007 082416040020 082416100016 082416130020 082416130021 082416130025 082416220006 82406040022 82406120016 82416130010 82416130011 82416130013 82416140005 82416160005 82416160010 514842AINNOVA 613548INNOVA3 4163694100 250370INNOVA 306766INNOVA 416756INNOVA 514376INNOVA 514934BANGIO 519663INNOVA2 519685INNOVA 204787INNOVA1 CS1054VA01 HC0220XR07 407953XR01 487692XR01 UC1129XR33 FI1015VA02 FI1015VA01 M1230007 N4192927 R4211476 M4505274 00490VAS02 01278VAS01 10091VAS01 00095VAS07 00137VAS01 00171VAS01 00860VAS01 HU1039VA02 IE1100VA01 IL1043VA01 083006202101017 A5102671 A5163317 A5605732 A5105151 C5603903 XF0150 XF0151 XF0152 XF0153 XF0154 XF0155 XF0200 YV0006 YV0007 XF0156 YV0009 XF0022 XF0149 YV0001 YV0002 YV0004 0850060718 0850060720 0850060721 0850060722 0850060725 850060707 KW1001VA03 KW1001VA04 KW1018VA04 KW1013VA01 LB1037VA01 MA1020VA01 BRD0411 NO1015VA04 600042VA02 787620IN4100 787653INNOVA 600152VA01 RU2714VA01 RU2992VA01 RU1050VA03 RU1018VA03 RU1106VA02 SA1005VA06 E001RX08 0002603739 0002603828 06004VAS02, and 853060187
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated February 28, 2008.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
Software error, computer: GE Healthcare has become aware of an issue with Error Management affecting the Innova 2100, 3100/3100 IQ & 4100/4100IQ. It was reported that when the foot switch was pressed, the live monitor screen was blank and it looked like there were no X-rays being emitted. But the message "Acquisition in progress" was displayed on the DL monitor, even after the foot switch was released. The operator had to reset the system to clear the message. This issue raises potential safety concerns in particular in the X RAY and motion controls if the error management does not work properly. No injury was reported. However, the patient received a low, unnecessary x-ray dose.
VOLUME OF PRODUCT IN COMMERCE
1,129 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Hill-Rom 70 Semi-Electric Bed; Model HS-968. The bed is a general purpose bed for use with low to medium acuity patients in the home care environment. Recall # Z-0506-2009
CODE
Serial numbers: HC100001 through HC101261
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hill-Rom, Inc., Batesville, IN, by letter dated November 11, 2008.
Manufacturer: Power Metal Industry Kunshan Co., Lt, Kunshankunshan, China. Firm initiated recall is ongoing.
REASON
Failure, mechanical: If the bed mechanism is cranked downward when the bed is already in its lowest position, the springs may cause the bed to rise suddenly if the bed is empty, more slowly if occupied by a patient, or when the patient exits the bed.
VOLUME OF PRODUCT IN COMMERCE
597 beds
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Quantimetrix QuanTscopics Urine Microscopics Control. QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a means to validate the processing and is centrifugation of urine prior to microscopic analysis in compliance with CLIA regulations. Recall # Z-0513-2009;

b) Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended use is to validate the performance of the Multistix, Chemstrip, Uriscan, QuickVue, Diascreen and other urinalysis reagent strips, and as a control for confirmatory tests such as Acetest, Clinitest, and Icotest reagent tablets, and as a control for hCG methods. In addition, the Dip and Spin Control is intended as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment. Recall # Z-0514-2009;

c) Quantimetrix SpinalScopics Spinal Fluid Cell Count Control. Spinalscopics is a plastic bottle liquid spinal fluid cell count control. This product is intended for monitoring cell counts in patient cerebrospinal fluid samples performed manually using a hemocytometer. Recall # Z-0515-2009;

d) Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial fluid samples performed manually using a hemocytometer. It is also an aid for identifying the crystals which may indicate a pathological condition present in the Synovial fluid. This control is used as a third party control to confirm proper functioning of the analysis by microscopic evaluation. Recall # Z-0516-2009
CODE
a) Lot Numbers: 48170, 48171, 48172, 48180, 48181 and 48182;

b) Lot Numbers: 47160, 47170, 47180, 47190, 47200 and 47210;

c) Lot Numbers: 46130, 46131, 46132, 46140, 46141, 46142, 46150, 46151, 46152, 46160, 46161, 46162, 46170, 46171 and 46172;

d) Lot Numbers: 38050 and 38060
RECALLING FIRM/MANUFACTURER
Quantimetrix Corp., Redondo Beach, CA, by letter dated June 8, 2008. Firm initiated recall is complete.
REASON
This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.
VOLUME OF PRODUCT IN COMMERCE
24,937 sets for all products
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
Vertical drive brake on patient supports. Used on certain Philips Medical Systems MX series and Brilliance series CT scanners. The device is a vertical drive brake that controls the vertical position of a patient support system or couch. The patient support system is intended to be used to place the patient in the correct horizontal and vertical position in order to be scanned. The couch is an accessory product to a computed tomography scanner. Recall # Z-0597-2009
CODE
Assembly number: 4535 664 98912
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letters on November 15, 2007 and June 6, 2008. Firm initiated recall is ongoing.
REASON
The patient support may travel downwards without being commanded to move.
VOLUME OF PRODUCT IN COMMERCE
559 units
DISTRIBUTION
Nationwide, and countries of Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Egypt, England, France, Germany, Greece, China, India, Indonesia, Ireland, Iraq, Italy, Japan, Jordan, Korea, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, South Africa, South Korea, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela
___________________________________
PRODUCT 
a) Alimed Gait Belt (Transfer Aid), Antimicrobial Plastic buckle, 54" Model: 72108.
Recall # Z-0598-2009;

b) Alimed Gait Belt (Transfer Aid), Antimicrobial Plastic buckle, 70" Model: 72109.
Recall # Z-0598-2009
CODE
a) Lot Numbers: Y8739, Y8296, Y7619, Y7004, Y5966 and Y3169;
b) Lot Numbers: Y3356 and Y3170
RECALLING FIRM/MANUFACTURER
AliMed Corp., Dedham, MA, by letter dated October 30, 2008. Firm initiated recall is ongoing.
REASON
Misassembled gait (transfer aid) belt.
VOLUME OF PRODUCT IN COMMERCE
993 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Esmark Elastic Bandage, 3” x 4” yards, sterile, for single use only, latex free. Catalog number: 23580-034. The device is used to promote blood flow from the extremities by compressing the superficial vessels. Recall # Z-0615-2009;

b) Esmark Elastic Bandage, 4” x 3” yards, sterile, for single use only, latex free. Catalog number: 23580-043. The device is used to promote blood flow from the extremities by compressing the superficial vessels, Recall # Z-0616-2009
CODE
a) Work order numbers: 304696 and 312977;
b) Work order numbers: 310652, 316815, 324060 and 327413
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, McGaw Park, IL, by letter dated November 17, 2008.
Manufacturer: Convertors De Mexico, S.A. De C.V., Ciudad, Juarez, Mexico. Firm initiated recall is ongoing.
REASON
The natural rubber latex bandages were mislabeled as latex free.
VOLUME OF PRODUCT IN COMMERCE
9,521 units
DISTRIBUTION
Nationwide, Guam and Korea
___________________________________
PRODUCT 
Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (SV3 Shroud Retro Fit Kit) and 0682-000-416 (Flat Panel Retro Fit Kit); The 0682-000-414 (FP Shroud version 2 reworked) is a shroud designed to cover the cabling necessary on a Stryker Version 3 Monitor when mounted on the Flat Panel Arm.  Recall # Z-0625-2009
CODE
All product shipped between 06/05/06 and 01/31/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Communications Corp., Flower Mound, TX, by letter on September 2, 2008
Manufacturer: Ondal Indust Gmbh, Hunfeld, Germany. Firm initiated recall is ongoing.
REASON
Paint chips: Shroud used to cover cables on the Stryker Vision 3 flat panel monitor (monitor used in surgery rooms during procedures) was not manufactured/painted to specification, resulting in the possibility that paint chips could fall off and fall into non-sterile and/or sterile fields during surgery.
VOLUME OF PRODUCT IN COMMERCE
116 units
DISTRIBUTION
Nationwide, Canada, Spain and the UK
___________________________________
PRODUCT 
Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant. Product is used to lubricate vulvar and vaginal tissues to facilitate entry of diagnostic or therapeutic devices. Pre' Lubricant is acceptable for use to facilitate insertion of diagnostic or therapeutic devices during fertility interventions such as: embryo transfer, transvaginal collection of oocytes, intrauterine insemination and post coital testing. In addition, product may be used as a personal lubricant to supplement the body's own natural lubricating fluids. Recall # Z-0626-2009
CODE
Lot number: 5213
RECALLING FIRM/MANUFACTURER
Recalling Firm: INGfertility, LLC, Valleyford, WA, by telephone on September 22, 2008.
Manufacturer: Unicep Packaging, Inc., Sandpoint, ID. Firm initiated recall is ongoing.
REASON
Product contaminated with bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and Ireland
___________________________________
PRODUCT 
TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. TomoTherapy HI-ART Systems is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital health tissue. The HI-Art system's planning station or operator station is intended to be used by the physician/oncologists to prescribe a radiation therapy plan for a particular patient,. The HI-ART System then calculates the treatment plan which the physician reviews and approves. The HI-ART system's operator station and status console is then intended to be used by the therapist to select and implement the patient's treatment plan. The treatment process will begin by performing a TomoImage (MVCT) scan (a CT using the on board linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient's position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The TomoImage (MVCT) image is not for diagnostic use. When patient positioning is complete, the HI-ART System i sthen intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment in accordance with the physician approved plan delivered in a helical tomographic pattern. Recall # Z-0628-2009
CODE
Domestic Customer Information Serial number: 110001 110002 110003 110004 110005 110006 110007 110008 110012 110013 110015 110016 110017 110019 110020 110021 110022 110023 110024 110025 110026 110027 110028 110029 110030 110031 110032 110033 110035 110038 110039 110040 110041 110042 110043 110044 110045 110047 110048 110050 110051 110053 110054 110056 110057 110059 110060 110066 110067 110073 110074 110080 110081 110082 110084 110086 110087 110089 110090 110091 110092 110094 110095 110096 110097 110098 110100 110103 110104 110105 110106 110108 110112 110115 110116 110118 110119 110120 110122 110127 110132 110134 110135 110138 110139 110141 110144 110145 110148 110149 110152 110153 110154 110155 110158 110160 110161 110165 110166 110168 110173 110174 110175 110176 110177 110179 110180 110181 110185 110186 110187 110188 110190 110192 110193 110195 110196 110197 110198 110201 110202 110203 110204 110206 110209 110210 110213 110214 110215 110216 110217 110221 110222 110223 110225 110227 110238 110242 110224 and 110250; International Customer Information Serial number: 110009 110014 110018 110034 110036 110037 110046 110049 110052 110055 110058 110061 110062 110063 110064 110065 110068 110069 110071 110072 110075 110076 110077 110078 110079 110083 110085 110088 110093 110107 110109 110110 110111 110113 110114 110117 110123 110124 110126 110128 110129 110130 110131 110133 110136 110137 110140 110142 110143 110146 110150 110151 110156 110157 110159 110162 110164 110167 110169 110170 110171 110172 110178 110182 110183 110189 110191 110194 110199 110200 110207 110211 110228 110237 and 110240
RECALLING FIRM/MANUFACTURER
TomoTherapy, Inc., Madison, WI, by letter dated October 17, 2008. Firm initiated recall is ongoing.
REASON
A potential issue with the Hi-Art system during the course of ongoing testing. The Operator Station Calibration panel provides access to view and modify machine specific configuration settings. Access to these settings has always been restricted to individuals with appropriate security rights, being limited to only the "Superuser" and "Field Service engineer" categories. Other security level users, including "Therapist", cannot modify these settings. In the calibration panel, it is possible for "Superuser" and "Field Service Engineer" user types to manually disable the front and back jaw potentiometer interlock. This interlock is always correctly enabled prior to factory shipment of systems from TomoTherapy, and there are no service procedure that requires the interlock to be disabled. If this setting were to be manually disabled, the jaw would not perform a verification of the pre-procedure homing routine. In the unlikely event that this verification routine failed in a rare and very specific manner, the jaws could position incorrectly for that procedure without a system interlock occurring. This positioning error could only result in a field width that is smaller than planned. Fractions that would be affected would only be those incurring the unusual chain of events outlined above. Regardless, overdose in not a possible outcome.
VOLUME OF PRODUCT IN COMMERCE
215 units
DISTRIBUTION
Nationwide, and countries of Belgium, Canada, Switzerland, China, Germany, Spain, France, Great Britain Hong Kong, Italy, Japan, Korea, Netherlands, Singapore, Taiwan and Turkey
___________________________________
PRODUCT 
Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0. Product is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Recall # Z-0629-2009
CODE
All units that have MP software version 3.0 and the Iris Collimator in clinical use at the same time.
RECALLING FIRM/MANUFACTURER
Accuray, Inc., Sunnyvale, CA, by letter dated November 14, 2008. Firm initiated recall is ongoing.
REASON
System may use random incorrect data to calculate dose. Resulting dose calculation can exceed 100% of correct dose.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump. Recall # Z-0652-2009
CODE
Lot number: 08E0451
RECALLING FIRM/MANUFACTURER
Stryker Endoscopy, San Jose, CA, by letter on October 1, 2008. Firm initiated recall is ongoing.
REASON
Unable to pump fluids. Silicone tubing is stiffer than usual, resulting in motor defect message, leading to inability to pump saline through tubes for surgery.
VOLUME OF PRODUCT IN COMMERCE
1,440 devices
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
a) Tornier AFFINITI Humeral Stem Standard 10mm, Catalog No. 0020010. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0818-2009;

b) Tornier AFFINITI Humeral Stem Standard 14mm, Catalog No. 0020014. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0819-2009;

c) Tornier AFFINITI Humeral Head Eccentric 44mm x 18mm, Catalog No. 0020025. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0820-2009;

d) Tornier AFFINITI Humeral Head Eccentric 44mm x 21mm, Catalog No. 0020026. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0821-2009;

e) Tornier AFFINITI Humeral Head Eccentric 48mm x 21mm, Catalog No. 0020030. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0822-2009;

f) Tornier AFFINITI Humeral Head Eccentric 52mm x 21mm, Catalog No. 0020034. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0823-2009;

g) Tornier AFFINITI Humeral Head Eccentric 56mm x 21mm, Catalog No. 0020038. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0824-2009;

h) Tornier AFFINITI Humeral Head Standard 44mm x 15mm, Catalog No. 0020044. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0825-2009;

i) Tornier AFFINITI Humeral Head Standard 44mm x 18mm, Catalog No. 0020045. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0826-2009;

j) Tornier AFFINITI Humeral Head Standard 44mm x 21mm, Catalog No. 0020046. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0827-2009;

k) Tornier AFFINITI Humeral Head Standard 48mm x 15mm, Catalog No. 0020048. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0828-2009;

l) Tornier AFFINITI Humeral Head Standard 48mm x 18mm, Catalog No. 0020049. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0829-2009;

m) Tornier AFFINITI Humeral Head Standard 48mm x 21mm, Catalog No. 0020050. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0830-2009;

n) Tornier AFFINITI Humeral Head Standard 52mm x 15mm, Catalog No. 0020052. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0831-2009;

o) Tornier AFFINITI Humeral Head Standard 52mm x 18mm, Catalog No. 0020053. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0832-2009;

p) Tornier AFFINITI Humeral Head Standard 52mm x 21mm, Catalog No. 0020054. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0833-2009;
 
q) Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020057. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0834-2009;

r) Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020058. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head. Recall # Z-0835-2009
CODE
a) Lot No: AA1234;
b) Lot No: AA1434;
c) Lot No’s: AA1157C, and AA1435;
d) Lot No’s: AA1158C, and AA1436;
e) Lot No: AA1303;
f) Lot No’s: AA1305, and AA1214;
g) Lot No: AA1307;
h) Lot No: AA1437;
i)  Lot No’s: AA1146C, and AA1438;
j)  Lot No: AA1290;
k) Lot No: AA1291;
l)  Lot No: AA1292;
m) Lot No: AA1293;
n) Lot No: AA1294;
o) Lot No’s: AA1295, and AA1439;
p) Lot No: AA1440;
q) Lot No: AA1298;
r)  Lot No’s: AA1208, and AA1442
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tornier, Stafford, TX, by letter dated October 17, 2008.
Manufacturer: Micropulse, Inc., Columbia City, IN. Firm initiated recall is ongoing.
REASON
Tornier, Medical has received a report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AFFINITI Stems.
VOLUME OF PRODUCT IN COMMERCE
401 units
DISTRIBUTION
AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI
___________________________________
PRODUCT 
Dri-Lok Disposable Cannula, Part numbers 3910-075-500, 3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090-502, 3910-090-650, 3910-090-652, 3910-090-800, and 3910-090-802. The obturator is used to create an opening into the patient's joint and is removed after the cannula is inserted. The cannula then allows instruments and scopes access to the joint while maintaining a seal against the loss of saline fluid used to keep the joint clean. The seal is formed by two elastomeric valves. The first controls loss of water when there is no instrument or scope therein, while the second provides a seal when the cannula is in use. The valves operate automatically. Recall # Z-0868-2009
CODE
Lot numbers: 08135AG2 through 08294AG2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Endoscopy, San Jose, CA, by telephone, e-mail and letter dated December 1, 2008.
Manufacturer: Stryker, Arroyo, PR. Firm initiated recall is ongoing.
REASON
Leak-resistant barrier may not properly seal and leak when an instrument is inserted, and keep leaking after instrument is removed.
VOLUME OF PRODUCT IN COMMERCE
4,914 boxes (24,570 units)
DISTRIBUTION
Nationwide, Australia, Brazil, Canada, Chile, China, France, Germany, Greece, India, Italy, New Zealand, Poland, Portugal, Sweden, Spain, Singapore, Switzerland, and UK.

END OF ENFORCEMENT REPORT FOR JANUARY 28, 2009

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