Enforcement Report

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

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November 22, 2006
06-47

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
Paxil CR (Paroxetine HCl) controlled-release tablets, 37.5 mg, 30 tablet bottles, Rx only, NDC 0029-3208-13, Recall # D-399-7
CODE
Lots: 303-6P08, exp 3/08; 304-6P08, exp. 3/08; 305-6P08, exp. 3/08
RECALLING FIRM/MANUFACTURER
Sb Pharmco Puerto Rico Inc., Cidra, PR, by telephone, on September 8, 2006. Firm initiated recall is ongoing.
REASON
Due to an intermittent manufacturing equipment malfunction some tablets may not contain active ingredient.
VOLUME OF PRODUCT IN COMMERCE
211,677/30 tablet bottles
DISTRIBUTION
Nationwide, Hawaii, and PR

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 4 fl oz bottles, Rx only, NDC 60432-089-04, Recall # D-400-7
CODE
Lot 27583A, exp. 2/07
RECALLING FIRM/MANUFACTURER
Morton Grove Pharmaceuticals, Inc., Morton Grove, IL, by letter dated October 13, 2006. Firm initiated recall is ongoing.
REASON
One individual unknown impurity level exceeds specification.
VOLUME OF PRODUCT IN COMMERCE
528/4 fl. oz. bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0097-7;
b) Platelets, Leukocytes Reduced, Recall # B-0098-7
CODE
a) and b) Unit: 032KE88517
RECALLING FIRM/MANUFACTURER
American National Red Cross, Badger-Hawkeye Region, Madison, WI, by telephone on October 13, 2003 or facsimile on October 14, 2003. 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
WI

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0246-7
CODE
Units: 20727-0712, 20728-7723
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated April 6, 2005.
Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for Cytomegalovirus (CMV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0249-7
CODE
Unit: 16455-4251
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on December 16, 2003.
Manufacturer: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was incorrectly tested for the antibody to the hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS

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PRODUCT
Red Blood Cells, Recall # B-0269-7
CODE
Unit: 6273114
RECALLING FIRM/MANUFACTURER
New York Blood Center Inc., New York, NY, by letter dated May 26, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0271-7;
b) Plasma Frozen, Recall # B-0272-7
CODE
a) Units: 042FF96397, 042FF96852;
b) Unit: 042FF96938
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on December 31, 2005 and follow-up letters on January 4, 2006. Firm initiated recall is complete.
REASON
Blood products, collected in manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0275-7;
b) Platelets Leukocytes Reduced, Recall # B-0276-7
CODE
a) and b) Units: 042X08826, 042FP08598
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on November 14, 2005 and follow-up letter dated November 29, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited an area endemic for malaria were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OH

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0277-7;
b) Platelets Leukoreduced, Recall # B-0278-7
CODE
a) and b) Unit: 033GL59440
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by fax on July 11, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CT

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PRODUCT
a) Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-0279-7;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-0280-7
CODE
a) Units: 9000611 (split product);
b) Unit: 6878287
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on February 1, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

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PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0281-7;
b) Recovered Plasma, Recall # B-0282-7 (1 unit)
CODE
a) and b) Unit: 7675411
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Beaumont, TX, by fax on June 16, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Switzerland

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PRODUCT
a) Platelet Pheresis Leukocytes Reduced, Recall # B-0285-7;
b) Platelet Pheresis Leukocytes Reduced Irradiated, Recall # B-0286-7
CODE
a) and b) Unit: 035Z19202
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on May 17, 2006 and follow-up letters dated May 23, 2006. Firm initiated recall is complete.
REASON
Blood products, that did not meet QC specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
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PRODUCT
Source Plasma, Recall # B-0288-7
CODE
Units: 05FIND1700, 05FIND2073, 05FIND2700, 05FIND3659
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Fort Wayne, IN, by fax on May 12, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA

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PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0290-7;
b) Fresh Frozen Plasma, Recall # B-0291-7
CODE
a) Units: 2234392, 2220342, 2172721;
b) Unit: 2172721
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva Inc., Newark, DE, by telephone July 25, 2006 and follow-up letter dated September 6, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had previously been deferred after reporting a positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
DE and MD

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0321-7
CODE
Unit: 22LZ11336
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on June 23, 2006 and by letter dated June 27, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

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PRODUCT
Source Plasma, Recall # B-0322-7
CODE
Units: 04YARB6415, 04YARB7014, 04YARB7409
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fayetteville, AR, by facsimile on February 2, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC

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PRODUCT
a) Red Blood Cells, Recall # B-0323-7;
b) Platelets, Recall # B-0324-7;
c) Recovered Plasma, Recall # B-0325-7
CODE
a), b), and c) Unit: 4434720
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on June 14, 2006 or June 16, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL, PA, and Switzerland

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PRODUCT
Source Plasma, Recall # B-0326-7
CODE
Unit: 6140070227
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Evansville, IN, by facsimile on April 24, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0327-7
CODE
Unit: 17203-5830
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by telephone on May 7, 2004. 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
TX

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PRODUCT
Source Plasma, Recall # B-0328-7
CODE
Units: 06FINA3067, 06FINA3669, 06FINA4072
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Ft. Wayne, IN, by facsimile on May 15, 2006. Firm initiated recall is complete.
REASON
Blood products, which tested negative for viral markers, but were not properly quarantined after the receipt of post donation information related to a recent tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA

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PRODUCT
Source Plasma, Recall # B-0329-7
CODE
Units: 05FIND7561, 05FIND7950
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Ft. Wayne, IN, by facsimile on May 10, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a doner who received a tattoo and piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0333-7
CODE
Unit: 20729-7376
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lafayette, LA, by telephone on April 4, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

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PRODUCT
a) Red Blood Cells, Apheresis, Leukocytes Reduced, Recall # B-0349-7;
b) Platelets, Pheresis, Leukocytes Reduced, Recall # B-0350-7
CODE
a), and b) Unit: 13X06144
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on February 8, 2006 and by letter on February 9, 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
2 units
DISTRIBUTION
MI

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0351-7
CODE
Unit: 2430074
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by facsimile on August 2, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

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PRODUCT
Recovered Plasma, Recall # B-0099-7
CODE
Unit: 032KE88517
RECALLING FIRM/MANUFACTURER
American National Red Cross, Badger-Hawkeye Region, Madison, WI, by facsimile on October 13, 2003. 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
1 unit
DISTRIBUTION
VA

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0240-7;
b) Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0241-7
CODE
a) Unit: 20726-8478;
b) Units: 20726-0288 (split unit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated January 31, 2005.
Manufacturing Firm: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to the use of the medication, Isoniazid, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
LA, and TX

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PRODUCT
Red Blood Cells, Recall # B-0267-7
CODE
Units: G56287, G56279, G56278, G56268, G56257, G56265
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by fax and follow-up letters on June 29, 2006. Firm initiated recall is complete.
REASON
Blood products, collected using a trip scale for which daily QC was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
IL

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PRODUCT
Recovered Plasma, Recall # B-0270-7
CODE
Unit: 6273114
RECALLING FIRM/MANUFACTURER
New York Blood Center Inc., New York, NY, by letter dated May 26, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

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PRODUCT
Red Blood Cells, Recall # 0273-7
CODE
Units: C40807, C40817
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by letter dated July 21, 2006. Firm initiated recall is complete.
REASON
Blood products, processed at an unacceptable temperature were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0287-7
CODE
Units: 177342499, 177342500, 177342488, 177342496
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., McAllen, TX, by letter dated November 18, 2004. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of acceptable temperatures during shipping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX
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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0306-7
CODE
Units: 4140956 (distributed as a split product)
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on July 27, 2006 and follow-up letter on July 31, 2006. Firm initiated recall is complete.
REASON
Blood products, possible contaminated with Gram positive cocci, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0334-7
CODE
Units: 16383-7975 and 16383-9954
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Maridian, MS, by telephone on July 18, 2005. Firm initiated recall is complete.
REASON
Blood products, labeled with an extended expiration time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
a) Allura X-per FD 10/10 x-ray, and fluoroscopy, Recall # Z-0165-2007;
b) Allura Xper FD 20/10 x-ray, and fluoroscopy, Recall # Z-0166-2007
CODE
a) 127, 113, 117, 112, 131, 128, 90, 17, 35, 137, 93, 51, 95, 27, 6, 47,
98, 22, 49, 39, 103, 120, 21, 40, 70, 101, 69, 94, 89, 23, 33, 31, 30,
29, 28, 32, 100, 63, 61;
b) 82, 33, 73, 24, 36, 71, 34, 52, 18, 19, 56, 67, 32, 22, 23, 54, 74, 69, 38
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on October 612, 2006.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue.
VOLUME OF PRODUCT IN COMMERCE
58 devices
DISTRIBUTION
Nationwide

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PRODUCT
Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R), Recall # Z-0167-2007
CODE
Software Versions: 8:00, 8.01, 8.02, 8.03 or 8..04
RECALLING FIRM/MANUFACTURER
Data Innovations, Inc., South Burlington, VT, by an email listserv notification and by letter dated 8/17/06. Firm initiated recall is ongoing.
REASON
Patient results may be associated with an incorrect specimen.
VOLUME OF PRODUCT IN COMMERCE
187 devices
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R, Recall # Z-0169-2007
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div, Mc Gaw Park, IL, by letters dated September 6, 2006.
Manufacturer: Baxter Healthcare Corporation, Largo FL. Firm initiated recall is ongoing.
REASON
The Meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring.
VOLUME OF PRODUCT IN COMMERCE
2,823 units
DISTRIBUTION
Nationwide, Hong Kong, Korea, and China

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PRODUCT
5 Qt. Wallmount Sharps Container, Model 150, Regular Size; colors 202 Beige, 030 Red, 040 Yellow, 24 count containers, Recall # Z-0170-2007
CODE
BEMIS: Model 7H150 020 includes lot 20060001 to 20060016; BEMIS: Model 7H150 030 includes lot 20050006, 20060001 to 20060008; BEMIS: Model 7H150 040 includes lot 20060001 to 20060008; Medline Model 7H950 030 includes lot 20050027, 20060001 to 20060008.
RECALLING FIRM/MANUFACTURER
Bemis, Sheboygan Falls, WI, by letters on August 23, 2006, and September 13, 2006. Firm initiated recall is ongoing.
REASON
The 5 Quart Wall Safes are shipped as two pieces (bottom & top) that customers are unable to assemble because of excess warp in the back wall of the container.
VOLUME OF PRODUCT IN COMMERCE
145,656 units
DISTRIBUTION
Nationwide and Canada

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PRODUCT
Medtronic Sofamor Danek, Bone Fragmentor, Ref Number 9150111- Device, Recall # Z-0176-2007
CODE
Lot numbers: 36197, 36200, 36298, 36199, 36196, 40591, 54685, 70942, 70605, 74679, 18150, 20271, 7935
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Sofamor Danek USA Inc., Memphis, TN, by letter on October 20, 2006.
Manufacturer: Lenox-Maclaren Surgical Corp., Louisville, CO. Firm initiated recall is ongoing.
REASON
Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.
VOLUME OF PRODUCT IN COMMERCE
255 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed Linvatec, Hall. Versipower, Versipower Plus Handpieces) and sold individually, Recall # Z-0179-2007
CODE
All Serial numbers
RECALLING FIRM/MANUFACTURER
Linvatec Corp., Largo, FL, by letter on December 20, 2005. Firm initiated recall is ongoing.
REASON
The Sternum Saw Collet Nut that is used to insert and hold the saw blade in place may not always allow for the easy insertion of a saw blade into the handpiece for use. The nut needs to be in a certain position in order for the blade to be inserted and this may delay the operation of the device especially in emergency situations.
VOLUME OF PRODUCT IN COMMERCE
11,424 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
MIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electrodes, Disposable, Sterile Single Use Device, Part #30-0012 and Model #30-0002. The electrodes are individually packaged in Tyvek bags with 12 packages per case, Recall # Z-0182-2007
CODE
Lot Numbers: 110201, 116228, 117331, 117985, 120959 and 000501; Lot Numbers: 110101, 113523, 113877, 114428, 114527, 115294, 115420, 119874, 120223, 120732 and 120883
RECALLING FIRM/MANUFACTURER
Olsen Medical, Louisville, KY, by letter and e-mail August 29 - 30, 2006. Firm initiated recall is ongoing.
REASON
Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user.
VOLUME OF PRODUCT IN COMMERCE
81 cases/972 pieces
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
a) M3001A Philips Multi Measurement Server (MMS), Recall # Z-0183-2007;
b) M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry
Nellcor OxiMax Compatible used with the IntelliVue or M3/M4 patient
monitor M1002, Recall # Z-0184-2007
CODE
a) HW Revision B: M3001 A #AO1 with S/N DE512xxxx
M3001A #A02 with S/N DE512xxxx
HW Revision C M3001A #A01 and #A02 with S/N DE610xxxx
With Sp)2 Firmware (Fw) Rev.: Sp02 DSP FW-Rev: A.01.41 or A.01.42;
b) M1020B #AO01 AND #A02 with S/N DE524xxxxx
M102B #A01 and #A02 with S/N DE612xxxxx
With Sp02 Firmware (Fw) Rev: Sp02 DSP Fw-Rev. A.01.42
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, Andover MA., by letter on September 21, 2006.
Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Hewlett-Packard Strasse 2, Boblingen, Germany. Firm initiated recall is ongoing.
REASON
Unexpected pulse oximetry (Sp02) readings (100%) over time when a sensor is not attached to the patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM.
VOLUME OF PRODUCT IN COMMERCE
70,138 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) ambIT Ambulatory Infusion Pump Cassette; Filterless, Spike, Sterile,
Vol. 2.3ml, REF 220139, Recall # Z-0185-2007;
b) ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile,
Vol. 2.3ml, REF 220140, Recall # Z-0186-2007;
c) ambIT Ambulatory Infusion Pump Cassette; Filter, Male, Sterile,
Vol. 2.3ml, REF 220266, Recall # Z-0187-2007;
d) ambIT Ambulatory Infusion Pump Cassette; Filterless, Male, Sterile,
Vol. 2.3ml, REF 220267, Recall # Z-0188-2007
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Sorenson Medical, Inc., West Jordan, UT, by letter on October 10-11, 2006. Firm initiated recall is ongoing.
REASON
Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
VOLUME OF PRODUCT IN COMMERCE
41,113 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Doc-U-Dose Prescription Management System, Item 8-PKIT. The product is packaged and distributed in cartons. Each carton contains 1,000 sets of four packets or 4,000 individual packets per carton, Recall # Z-0189-2007
CODE
Carton numbers: 16 through 39 were subject to recall.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eatonform Inc., Dayton OH, by letter on September 28, 2006.
Manufacturer: Specialized Printed Forms, Caledonia NY. Firm initiated recall is ongoing.
REASON
The poly film may separate along the sealed seams of the packets of the Doc-U-Dose Prescription Management System causing the medications to unintentionally fall out of the packets prior to delivery to patient/consumers.
VOLUME OF PRODUCT IN COMMERCE
24 cartons/24,000 packets
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. The Distal Thread Reduction Guide Pin is a reusable instrument that is part of a set of instruments used to perform reduction surgeries with the ST360 Spinal Fixation System. The ST360 Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, fixed and adjustable transverse connectors, Recall # Z-0190-2007.
CODE
Lot numbers: P031530, P031650, P040389, P040111, P051160, P051161
RECALLING FIRM/MANUFACTURER
Zimmer Spine, Inc., Minneapolis MN., by letters beginning October 12, 2006. Firm initiated recall is ongoing.
REASON
Recall is due to an issue with the thread timing.
VOLUME OF PRODUCT IN COMMERCE
159 units
DISTRIBUTION
Nationwide and Japan

______________________________
PRODUCT
BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System, Recall # Z-0193-2007
CODE
Serial numbers B-102 through B-184
RECALLING FIRM/MANUFACTURER
Trionix Research Laboratory, Inc., Twinsburg, OH, by telephone on/about November 2, 2006. Firm initiated recall is ongoing.
REASON
The ball screw on the unit which supports the detector head (which weights approximately 800 lbs.) could snap resulting in the detector head dropping on the patient.
VOLUME OF PRODUCT IN COMMERCE
76 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C, C/D EX) and 2300 C, C/D EX), Recall # Z-0194-2007
CODE
Serial numbers H272325, H291060, H271879, H273040, H272187, H272434
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Inc., Palo Alto, CA, by letters on August 31, 2006. Firm initiated recall is ongoing.
REASON
The chain holding the device gantry in position may break.
VOLUME OF PRODUCT IN COMMERCE
254 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Lysus Transport Stand (infusion stand), part number 4896-003, Recall # Z-0195-2007
CODE
Serial numbers: 060113010-001, 060113010-002, 060113010-003, 060113010-004, 060113010-005, 060113010-006, 060113010-007, 060113010-008, 060113010-009, 060113010-010, 060113010-011, 060113010-012, 060113010-013, 060113010-014, 060113010-015, 060324025-001, 060324025-002 The additional carts do not contain any type of serial number.
RECALLING FIRM/MANUFACTURER
Ekos Corp., Bothell, WA, by letter, dated October 2, 2006. Firm initiated recall is ongoing.
REASON
Carts distributed without an additional caution label directly on the cart, alerting users to tipping hazard.
VOLUME OF PRODUCT IN COMMERCE
84 carts
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
a) Asahi APS Series Multiple-Use Hollow Fiber Dialyzers; a wet model
multiple use dialyzer consisting of hollow fiber membranes of polysulfone
housed within a plastic casing of styrene butadiene block polymer, filled at
the factory with fluid to facilitate priming by the user, and sterilized by gamma
radiation before shipment; Made in Japan; 12 units per case; Models APS-18R
and APS-900S - 1.8 m2 surface area, Model APS-21R and APS-1050S - 2.1 m2
surface area, Recall # Z-0171-2007;
b) Asahi Rexeed Series Multiple-Use Hollow Fiber Dialyzers; a wet model
multiple use dialyzer consisting of hollow fiber membranes of polysulfone/PVP
housed within a plastic casing of styrene copolymer, filled at the factory with
fluid to facilitate priming by the user, and sterilized by gamma radiation before
shipment; Made in Japan; 12 units per case; Model Rexeed-15R - 1.5 m2 surface
area, Model Rexeed-18R - 1.8 m2 surface area, Model Rexeed-21R - 2.1 m2
surface area, Model Rexeed-25R - 2.5 m2 surface area, Recall # Z-0172-2007;
c) Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model single or multiple
use dialyzer consisting of hollow fiber membranes of alkyl ether polymer
grafted cellulose housed within a plastic casing of styrene butadiene block
polymer, filled at the factory with fluid to facilitate priming by the user, and
sterilized by gamma radiation before shipment; Made in Japan; 12 units
per case; Model AM-BIO-65 - 1.3 m2 surface area, Model AM-BIO-75 – 1.5 m2
surface area and Model AM-BIO-100 - 2.0 m2 surface area, Recall # Z-0173-2007;
d) Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple
use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted
cellulose housed within a plastic casing of styrene butadiene block polymer,
sterilized by gamma radiation before shipment; Made in Japan; 12 units per case;
Model AM-BIO-75D - 1.5 m2 surface area and Model AM-BIO-100D - 2.0 m2
surface area, Recall # Z-0174-2007;
e) Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple
use dialyzer consisting of hollow fiber membranes of cuprammonium rayon
housed within a plastic casing of styrene butadiene block polymer, sterilized
by gamma radiation before shipment; Made in Japan; 12 units per case;
Model AM-NR-65U - 1.3 m2 surface area, Model AM-NR-75U - 1.5 m2 surface
area and Model AM-NR-100U - 2.0 m2 surface area, Recall # Z-0175-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Asahi Medical Co., Ltd., Northbrook, IL, by letters on October 12, 2006.
Manufacturer: Asahi Kasai Medical Co., Ltd., Oita Prefecture, Japan. Firm initiated recall is ongoing.
REASON
There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle.
VOLUME OF PRODUCT IN COMMERCE
100,000 units
DISTRIBUTION
Nationwide

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PRODUCT
Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570, Recall # Z-0177-2007
CODE
Lot #: 7513978, Expiration date 2008-03, may possibly be printed as 2008-4,
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Target, Fremont, CA., by letters on October 6, 2006.
Manufacturer: Boston Scientific Cork, LTD, Cork, Ireland. Firm initiated recall is ongoing.
REASON
Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct)
VOLUME OF PRODUCT IN COMMERCE
54 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Michigan Instruments Thumper Mechanical CPR Device, Model 1007, Part number 15000, Recall # Z-0178-2007
CODE
All serial numbers with 7-or 9 followed by 4 numbers, e.g. 7-xxxx or 9-xxxx.
RECALLING FIRM/MANUFACTURER
Michigan Instruments, Inc., Grand Rapids, MI, by letter dated September 14, 2006. Firm initiated recall is ongoing.
REASON
Failure to initiate compressions when turned on.
VOLUME OF PRODUCT IN COMMERCE
639 devices
DISTRIBUTION
Japan

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PRODUCT
a) VHS Pediatric Hip Screw System Ped VHS, Lag Screw Ref # 200516
Stainless Steel, Rx only, Recall # Z-0180-2007;
b) VHS Pediatric Plate (for hip screw system) Ref 200501,
VHS Pediatric Plate Stainless Steel Rx only, sterile, Recall # Z-0181-2007
CODE
a) 200511 Intermediate VHS Lag Screw 35MM. Lot #s 089397, 224149,
227018, 228282, 276052, 284944, 299271, 321772, 326236, 572150,
576380.
200512 Intermediate VHS Lag Screw 40 MM, Lot #s 115120,
172137, 257775, 271524, 297135, 299272, 572160, 576400.
200513 Intermediate VHS Lag Screw 45 MM, Lot #s 089398, 197199, 210829,
243847, 284087, 297136, 307909, 309419, 749310.
200514 Intermediate VHS Lag Screw 50 MM, Lot #s 115130, 174095, 224464,
276169, 276053, 284088, 299273, 326237, 749340.
200515 Intermediate VHS Lag Screw 55MM, Lot #s 089399,178703,2 24167,
275771, 297137, 321775, 326238, 333721, 572180, 576410.
200516 Intermediate VHS Lag Screw 60 MM, Lot #s 089400, 227860, 275775,
277702, 287521, 299274, 301001, 344610, 749350.
200517 Intermediate VHS Lag Screw 65 MM, Lot #s 089401, 224293, 275778,
284945, 297138, 299275, 321776, 749370.
200518 Intermediate VHS Lag Screw 70 MM, Lot #s 089402, 243848, 275780,
287522, 297139, 304127, 749380.
200519 Intermediate VHS Lag Screw 75 MM, Lot #s 089403,267170, 267172,
299276, 321777, 352316, 353922, 366390,749390.
200520 Intermediate VHS Lag Screw 80 MM, Lot #s 104564, 168448, 285930,
321778, 329174, 299277, 299278, 302214, 321784, 366400, 747410.
200521 Intermediate VHS Lag Screw 85 MM, Lot #s 089404, 267171, 275783,
299277, 299278, 302214, 321784, 366400, 747410.
200522 Intermediate VHS Lag Screw 90 MM, Lot #s 168449, 284947, 321782,
329175, 357520.
200523 Intermediate VHS Lag Screw 95MM, Lot #s 104567, 168294, 217920,
344219, 345861, 347823, 361016, 749420.
200524 Intermediate VHS Lag Screw 100MM, Lot #s 104570, 168450, 181749,
302216,312049,321786,342630,749430;
b) 200501 Intermediate VHS Plate Keyless 3 holes, Lot #s 074550, 186055,
210448, 212643, 257687, 272019, 296837, 299392, 344607, 355441,
586500, 591030, 881240.
200502 Intermediate VHS Plate Keyless 4 holes, Lot #s 118980, 187153, 190506,
224463, 227017, 271523, 287520, 299267, 344608, 586510, 591050.
200503 Intermediate VHS Plate Keyless 6 holes, Lot #s 178300, 223594, 246879,
257773, 297133, 299268, 326234, 366450, 749300.
200504 Intermediate VHS Plate Keyless 8 holes, Lot #s 112505, 257774, 299269,
326235, 344609.
200505 Intermediate VHS Plate Keyless 10 holes, Lot #s 112506, 149310, 299270.
RECALLING FIRM/MANUFACTURER
EBI, L.P., Parsippany NJ, by letter on September 6, 2006. Firm initiated recall is ongoing.
REASON
VHS Plate and lag screw components did not assemble correctly intraoperatively.
VOLUME OF PRODUCT IN COMMERCE
1,480 units
DISTRIBUTION
Nationwide

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