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U.S. Department of Health and Human Services

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Enforcement Report for October 18, 2006

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.

October 18, 2006
06-42

 

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
Gilpizide tablets, 10mg, Rx Only, 100 tablet bottles, NDC 0172-3650-60, Recall # D-002-7
CODE
Lot: 146630A, exp. 01/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL, by letters on July 11, 2006.
Manufacturer: IVAX Pharmaceuticals, Inc., Cidra, PR. Firm initiated recall is ongoing.
REASON
Incomplete laboratory testing investigation.
VOLUME OF PRODUCT IN COMMERCE
10,824/100 tablet bottles
DISTRIBUTION
KY and TN

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PRODUCT
Citalopram Hydrobromide tablets, 20 mg, Rx Only, NDC 0172-4741-60, Recall # D-003-7
CODE
Lot: 131890B, exp. 11/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL, by letter on July 11, 2006.
Manufacturer: IVAX Pharmaceuticals, Inc., Cidra, PR. Firm initiated recall is ongoing.
REASON
Incomplete laboratory testing Investigation.
VOLUME OF PRODUCT IN COMMERCE
9,648/100 tablet bottles
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Metformin Hydrochloride Extended-Release tablets, 500 mg, Rx Only,. 100 tablet bottles, NDC 0172-4435-60, Recall # D-004-7
CO/DE
Lot: 141330A, exp. 05/207
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL, by letter on July 11, 2006.
Manufacturer: IVAX Pharmaceuticals, Inc., Cidra, PR. Firm initiated recall is ongoing.
REASON
Unidentified foreign matter
VOLUME OF PRODUCT IN COMMERCE
14,397/100 tablet bottles
DISTRIBUTION
Nationwide and PR

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PRODUCT
Bumetanide tablets, 2mg, Rx Only, 100 tablet bottles, NDC 0172-4234-60, Recall # D-005-7
CODE
Lot 138184A, exp 06/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, MiamiFL, by letters on July 11, 2006.
Manufacturer: Ivax Pharmaceuticals, Inc., CidraPR. Firm initiated recall is ongoing.
REASON
Incomplete laboratory testing investigation.
VOLUME OF PRODUCT IN COMMERCE
9,504/100 tablet bottles
DISTRIBUTION
Nationwide, Hawaii, and PR
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0002-7
CODE
Unit: 53P98507
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Regions, Baltimore, MD, by telephone on March 21, 2005. Firm initiated recall is complete.
REASON
Platelets Pheresis, with an unacceptably low volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

______________________________
PRODUCT
Platelets, Recall # B-0004-7
CODE
Unit: LX15118
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Sterling, VA, by letter dated May 25, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

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PRODUCT
Red Blood Cells, Recall # B-0005-7
CODE
Unit: KS35337
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Sterling, VA, by letter dated January 4, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0006-7
CODE
Unit: 53GV64854
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Regions, Baltimore, MD, by letter dated April 28, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0007-7
CODE
Unit: 53LT87511 (part 1)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Regions, Baltimore, MD, by letter dated April 25, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0009-7
CODE
Unit: KZ98374
RECALLING FIRM/MANUFACTURER
Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by facsimile on July 29, 2004. 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
NJ

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0012-7
CODE
Unit: 53FQ00708
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Regions, Baltimore, MD, by telephone on March 4, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom documentation of a hematocrit test and body temperature during the donor screening process was discrepant, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

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PRODUCT
a) Red Blood Cells, Recall # B-0014-7;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0015-7;
c) Cryoprecipitated AHF, Recall # B-0016-7;
d) Plasma, Recall # B-0017-7;
e) Fresh Frozen Plasma, Recall # B-0018-7
CODE
a), c), d), Unit: H49390;
b), e) Unit: Y10295;
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated April 26, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of melanoma, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
VA

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PRODUCT
Source Plasma, Recall # B-0022-7
CODE
Units: 04NWVA4767, 04NWVA4899, 05NWVA0387, 05NWVA0599, 05NWVA0682, 05NWVA0898, 05NWVA0969, 05NWVA1209, 05NWVA1269, 05NWVA1483, 05NWVA1534, 05NWVA1761, 05NWVA1817, 05NWVA2056, 05NWVA2114, 05NWVA2347, 05NWVA2491, 05NWVA2742, 05NWVA2874, 05NWVA3043, 05NWVA3150
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Nutter Fort, WV, by facsimile on June 17, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of brain surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
CA

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0035-7;
b) Platelets, Recall # B-0036-7
CODE
a) and b) Unit: LS94522
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on April 26, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0037-7
CODE
Units: FT08289 and LN66079
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter on January 22, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0038-7
CODE
Unit: GR34535
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter on January 25, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0039-7
CODE
Unit: KM46136
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on April 22, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0040-7
CODE
Unit: 53F53247
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Regions, Baltimore, MD, by telephone on June 29, 2005 and by letter on September 6, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0001-7
CODE
Units: LM00051 (split unit)
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Sterling, VA, by letter dated May 5, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA

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PRODUCT
Plasma, Frozen, Recall # B-0008-7
CODE
Units: 53FM75530, 53FX09851, 53GE94315, 53H20520
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Regions, Baltimore, MD, by
facsimile on August 11, 2005. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood with an extended collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MD and DC

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PRODUCT
Platelets, Recall # B-0013-7
CODE
Unit: 53FQ00708
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Regions, Baltimore, MD, by telephone on March 4, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom documentation of a hematocrit test and body temperature during the donor screening process was discrepant, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
DC

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PRODUCT
Source Plasma, Recall #B-0025-7
CODE
Units: 04HWVD3111, 04HWVD5176, 04HWVD2288, 04HWVD2631, 04HWVD1007, 04HWVD1366, 04HWVD3173, 04HWVD4921, 04HWVC8972, 04HWVD1887, 04HWVD1702, 04HWVD2034, 04HWVD4286, 04HWVD2174, 04HWVC8913, 04HWVC9264, 04HWVC9650, 04HWVD0434, 04HWVD4175, 04HWVD2764, 04HWVD4334, 04HWVD3536, 04HWVD4584, 04HWVD4520, 04HWVD3966, 04HWVD4278, 04HWVD1082, 04HWVD0112, 04HWVD3564, 04HWVD4425, 04HWVD3512, 04HWVD5019, 04HWVD9567, 04HWVD9224
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Huntington, WV, by facsimile on January 7, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors who were not asked all of the medical history questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
NC

______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0041-7
CODE
Unit: 53GX29113
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Regions, Baltimore, MD, by telephone on September 29, 2005 and by letter dated September 30, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
DC
 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Numbers: Catalogue numbers: 100118--Short, 14mm graft: #100121--Long, 14mm graft; #100129--Long, 18mm graft, Recall # Z-0015-2007
CODE
Serial numbers:104, 106
RECALLING FIRM/MANUFACTURER
Thoratec Corp., Pleasanton, CA, by letters on January 26, 2004. Firm initiated recall is ongoing.
REASON
During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide and Australia

______________________________
PRODUCT
Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL, U770 GNDAL, Recall # Z-0016-2007
CODE
Model U 770, serial number range: 6149310001 - 6149310005, 6151360001 - 6151360005, 6163290001 - 616330001. Model U770 AL, serial number range: 6099280001 - 6113410042, 6114760001 - 6127920006, 6128720001 - 6130360001, 6130510001 - 6135430002, 6136650001 - 6140860005, 6142190001 - 6142320001, 6142380001 - 6148440006, 6149320001 - 6151270004, 6152090001 - 6160890005, 6161480001 - 6162420010, 6163330001 - 6168440002, 6169170001 - 6171470001, 6171750001 - 6174080020, 6174750001 - 6177310002. U770-GNDAL, serial number range: 6113510001 - 6113510004, 6127970001 - 61279700015, 6130370001 - 6130370003, 6135440001, 6140870001 - 61408700010, 6142330001, 6160900001 - 61609000010, 6168450001 - 6168450004, 6171700001 - 6171720002, 6174710001 - 61747100012
RECALLING FIRM/MANUFACTURER
Sunrise Medical CCG, Inc., Stevens Point, WI, by telephone beginning January 2006. Firm initiated recall is ongoing.
REASON
The control box used in the actuator systems appears to have a potential to become stuck in one position resulting a non-functioning bed.
VOLUME OF PRODUCT IN COMMERCE
6,921 beds
DISTRIBUTION
Nationwide and Canada

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PRODUCT
Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200, Recall # Z-0017-2007
CODE
All model P3200 VersaCare beds with the optional patient pendants P3207A01 or P3207A02.
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated August 10, 2006. Firm initiated recall is ongoing.
REASON
The patient pendant cord represents a potential trip hazard for the patient or the caregiver.
VOLUME OF PRODUCT IN COMMERCE
36,645 beds
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Abbott AxSYM system FSH Master Calibrators (LN 7A60-30),
for in vitro diagnostic use, Recall # Z-0023-2007;
b) FSH Calibrators (LN 9C06-01), for in vitro diagnostic use,
Recall # Z-0024-2007;
c) Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use,
Recall # Z-0025-2007
CODE
a) Lot# 33266Q100 Expiration Date 11/04/2006;
b) Lot # 33362Q100 Expiration Date 11/04/2006;
c) Lot # 33363Q100 Expiration Date 11/04/2006
RECALLING FIRM/MANUFACTURER
Abbott Diagnostic International, Ltd., Barceloneta,PR, by letter, on September 7, 2006. Firm initiated recall is ongoing.
REASON
Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
VOLUME OF PRODUCT IN COMMERCE
1,980 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant, Recall # Z-0027-2007
CODE
Lot numbers 2006-12 AA through 2008-06 AB.
RECALLING FIRM/MANUFACTURER
3M Company / Medical Division, South St PaulMN, by letters on August 14, 2006. Firm initiated recall is ongoing.
REASON
3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing.
VOLUME OF PRODUCT IN COMMERCE
6,248 cases (4 boxes per case)
DISTRIBUTION
Nationwide

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PRODUCT
Lumenis brand DuoTome SideLite(tm) 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01, Recall # Z-0028-2007
CODE
Lot/Batch Numbers: 37600206, 38030206, 38470206, 39110306, 39660406, 40480506, 41040506, 42110606, 42550706, 37640206, 38120206, 38480206, 39200306, 39670406, 40490506, 41050506, 42120606, 42560706, 37650206, 38150206, 38510206, 39210306, 39680406, 40520506, 41080506, 42200606, 42570706, 37660206, 38160206, 38520206, 39220306, 39690406, 40530506, 41090506, 42210606, 42580706, 37700206, 38170206, 38530206, 39240306, 39770406, 40570506, 41100506, 42280606, 42650706, 37710206, 38200206, 38700306, 39250306, 39800406, 40580506, 41210506, 42290606, 42680706, 37720206, 38210206, 38710306, 39260306, 39810406, 40590506, 41310506, 42300606, 42740706, 37730206, 38230206, 38720306, 39270306, 39820406, 40600506, 41360506, 42310606, 42810706, 37740206, 38240206, 38730306, 39280306, 39830406, 40610506, 41390506, 42320606, 42890706, 37750206, 38300206, 38740306, 39460306, 39840406, 40690506, 41450506, 42330606, 43000706, 37760206, 38310206, 38800306, 39470306, 39880406, 40710506, 41470506, 42350606, 43010706, 37770206, 38380206, 38810306, 39530306, 39890406, 40720506, 41500506, 42360606, 43060706, 37800206, 38390206, 38830306 39540306, 39900406, 40730506, 41610606, 42380606, 43150706, 37810206, 38400206, 38840306, 39550306, 40180406, 40930506, 41750606, 42410606, 43190706, 37820206, 38410206, 38920306, 39560306, 40200406, 40940506, 41880606, 42420606, 43200706, 37890206, 38420206, 38930306, 39570306, 40340406, 40960506, 41890606, 42430606, 43210706, 37910206, 38430206, 38970306 39580306, 40390406, 40970506, 41900606, 42460706, 43220706, 37960206, 38440206, 38980306, 39590306, 40430406, 40980506, 41930606, 42490706, 43270706, 37970206, 38450206, 38990306, 39600306, 40460506, 41020506, 41990606, 42500706, 43280706, 37980206, 38460206, 39000306, 39650306, 40470506, 41030506, 42000606, 42540706, 43410706
RECALLING FIRM/MANUFACTURER
Lumenis Inc., Santa Clara, CA, by letters and telephone on August 26, 2006. The firm initiated recall is ongoing.
REASON
Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use.
VOLUME OF PRODUCT IN COMMERCE
10,815 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J, Recall # Z-0029-2007
CODE
AIRIS - Serial Number Range: A001, AG001-AG039, A901; MRP-7000 - Serial Number Range: 7001- 7154.
RECALLING FIRM/MANUFACTURER
Hitachi Medical Systems America Inc, Twinsburg, OH, by letter on August 16, 2006. Firm initiated recall is ongoing.
REASON
Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate.
VOLUME OF PRODUCT IN COMMERCE
348 systems
DISTRIBUTION
Nationwide and PR

______________________________
PRODUCT
Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart, Recall # Z-0030-2007
CODE
MF5124329
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc, ReadingPA, by letter on June 20. 2006.
Manufacturer: Arrow International, Inc., Mount Holly,NJ. Firm initiated recall is ongoing.
REASON
The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
MD, IL, MO, MA and United Kingdom

______________________________
PRODUCT
CR DX-S, Image Intensified Fluoroscopic X-ray system, Recall # Z-0031-2007
CODE
Serial number SN1001- SN1179, and SN1181, SN1183 and SN1184; Software versions: STR_1207 and below.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter on June 28, 2006.
Manufacturer: AGFA Corp., Mortsel, Belgium. Firm initiated recall is ongoing.
REASON
Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Recall # Z-0032-2007
CODE
Serial numbers: PA0101 to PA0681
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO, by letter on May 16, 2006.
Manufacturer: Gambro Dasco S.p.A, Monitor Division, Medolla, Italy. Firm initiated recall is ongoing.
REASON
A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.
VOLUME OF PRODUCT IN COMMERCE
154 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
IMPAX® 5.2 Systems with CAD Capability (Computer Assisted Diagnosis), Recall # Z-0033-2007
CODE
Diagnostic Workstation/Impax 5.2/with CAD Capability/Flat Panel 60+00024433, Diagnostic Workstation/Impax 5.2/with CAD Capability/CRT: 60+00024432 and Clinical Review Station/Impax 5.2/with CAD Capability/Flat Panel: 60+00024438. Software version Impax 5.2.2 sites using CAD.
RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC, by letter on August 8, 2006. Firm initiated recall is ongoing.
REASON
Failed CAD displayed as 'No Findings'.
VOLUME OF PRODUCT IN COMMERCE
20 Impax 5.2 Mammo licenses
DISTRIBUTION
Nationwide

______________________________
PRODUCT
SmartSuction Harmony Powered Suction Device, Model number: HAR-E-115-US, Recall # Z-0035-2007
CODE
Serial Numbers: 06F018, 06E133, 06A294-2, 06E132, 06A289 Foreign: 06C251, 06C252, 06C253, 06C254, 06C255, 06C242, 05D074-1, 06D075-1, 06F014-1, 06C248
RECALLING FIRM/MANUFACTURER
Haemonetics Corp., Eastern Maine Medical Center, Braintree, MA, by letters on July 28, 2006. Firm initiated recall is complete.
REASON
Faulty circuit board may short circuit and cause electric shock to operator.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
Nationwide and Internationally
 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S, Recall # Z-0012-2007
CODE
Lot/Unit Codes: 976115CC, Serial Numbers: 2000509, 207025, 207557, 44993, 62774, 205928, 201933, 203550, 205927, 202939
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integrated Orbital Implants Inc, San Diego,CA, by email on February 27, 2006.
Manufacturer: Interpore Cross International Inc, IrvineCA. Firm initiated recall is complete.
REASON
The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Finland and France

END OF ENFORCEMENT REPORT FOR October 18, 2006

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