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U.S. Department of Health and Human Services

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Enforcement Report for September 13, 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.

 

September 13, 2006
06-37

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

*****CORRECTION*****

The August 30, 2006 -- 06-35 Enforcement Report, Class II, Recall # D-332-6/D-334-6 had several errors. The corrections are as follows:
PRODUCT
a) Levoxyl ® (Levothyroxine sodium tablets, USP), 75 mcg 100 count bottles,
Rx Only, NDA: 21-301 NDC: 52604-5075-1, Recall # D-332-6;
b) Levoxyl ® (Levothyroxine sodium tablets, USP), 112mcg, 100 and
1000-count bottles, Rx Only, NDA: 21-301 NDC: 52604-5112-1
and 52604-5112-2, Recall # D-333-6;
c) Levoxyl ® (Levothyroxine sodium tablets, USP), 125mcg, 100 and
1000-count bottles, Rx Only, NDA: 21-301 NDC: 52604-5125-2
and 52604-5125-1, Recall # D-334-6
CODE
a) Lot: 9240, SAP batch 21272;
REASON
Potential sub-potency at expiry.

_____________________________
PRODUCT
Levoxyl (Levothyroxine sodium tablets, USP) 125 mcg, 100 count bottles, Rx only, Recall # D-356-6
CODE
Lot number 20784
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rx PAK, MemphisTN, by e-mail on August 1, 2006.
Manufacturer: King Pharmaceuticals, Inc. (St. Petersburg Facility), Saint Petersburg, FL. Firm initiated recall is complete.
REASON
Potential sub-potency at the 15 month stability interval
VOLUME OF PRODUCT IN COMMERCE
2020 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Levoxyl (Levothyroxine sodium tablets, USP) 112mcg, Rx, Item #537845. The medication is repackaged and distributed in 100 tablet bottles, Recall # D-357-6
CODE
Lot number: 053668, Expiration: 09/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH, by e-mail and letters on August 17, 2006.
Manufacturer: King Pharmaceuticals, Inc., (St Petersburg Facility), Saint Petersburg, FL. Firm initiated recall is ongoing.
REASON
Subpotent: The tablets have the potential to fail below the manufacturer’s potency specifications before their labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE
1,007 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Cocaine Hydrochloride Topical Solution 4% packed in 4mL glass bottles, Recall # D-335-6
CODE
Lot Numbers: 656429A - Expiration Date: Apr 07; and Lot #656795B, Expiration Date: May 07
RECALLING FIRM/MANUFACTURER
Boehringer Ingelheim Corporation, Columbus, OH, by letter on July 31, 2006. Firm initiated recall is ongoing.
REASON
Mislabeling: The folding carton for the Cocaine Hydrochloride 4% topical solution lists the incorrect milligram strength for the product.
VOLUME OF PRODUCT IN COMMERCE
44,452 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Baraclude (Entecavir) Oral Solution, 0.05 mg/mL, 210 mL, Rx only, NDC 0003-1614-12, Recall # D-351-6
CODE
Lots: 4M4305B, exp. 12/06; 4M4306B, exp. 12/06
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Company, Mead Johnson Park, Evansville, IN, by letters on August 17, 2006. Firm initiated recall is ongoing.
REASON
Lots do not meet specification for total impurities throughout indicated shelf life
VOLUME OF PRODUCT IN COMMERCE
439 bottles
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Rosaderm(tm) Cleanser * (Sodium Sulfacetamide 10% and Sulfur 5%) * Rx only: For dermatologic use only * Net Wt. 6 oz (170g), Recall # D-358-6
CODE
Various
RECALLING FIRM/MANUFACTURER
Harmony Labs, Inc, Landis,NC, by letter on July 25, 2006. Firm initiated recall is ongoing.
REASON
Subpotent: Product fails to support 24 months expiration date.
VOLUME OF PRODUCT IN COMMERCE
120,271 units
DISTRIBUTION
GA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
Source Plasma, Recall # B-1708-6
CODE
Units: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140, MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855, MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136, MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343, 04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504, 05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874, 05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236, 05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336, 05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907, 05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277, 05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355, 05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892, 05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from unsuitable donors based on risk factors for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
CA, NC, and MD

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1712-6;
b) Fresh Frozen Plasma, Recall # B-1713-6
CODE
a) and b) Unit: 4700310
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Inc., Tyler, TX, by telephone on April 24, 2003 and by letter dated May 30, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6;
b) Fresh Frozen Plasma, Recall # B-1715-6;
c) Platelets, Recall # B-1716-6
CODE
a), b), and c) Unit: 2443732
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by letters dated November 11, 2003 and December 18, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and WI

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Red Blood Cells, Recall # B-1710-6
CODE
Unit: 6697477
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 23, 2005. Firm initiated recall is complete.
REASON
Blood product, which was untested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1723-6
CODE
Units: 8147638, 8147639
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New York, NY, by telephone and letter dated May 21, 2002. Firm initiated recall is complete.
REASON
Blood products, labeled with an incorrect expiration date and product code, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

______________________________
PRODUCT
Bausch & Lomb * ReNu® with MoistureLoc®, Multi-purpose soft contact lens solution * Sterile, Recall # Z-1201-06
CODE
All lots, all sizes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb, Rochester, NY, by press release on April 13, 2006 and by letters on April 14, 2006.
Manufacturer: Bausch & Lomb, Greenville, SC. Firm initiated recall is ongoing.
REASON
Reports of Fusarium Infections among contact lens wearers
VOLUME OF PRODUCT IN COMMERCE
3 million bottles
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor). Model #D826, Part Number: 904-308, Recall # Z-1436-06
CODE
Lot Codes R0172 through R0223, inclusive, Expiration Date: Year-month listed on label.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by letter in November 2005.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall ongoing.
REASON
Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations
VOLUME OF PRODUCT IN COMMERCE
4517
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
FP1000 Cell Preparation System Part Number 624922, Recall # Z-1466-06
CODE
Software Version 1.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on June 26, 2006.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
During the cleaning cycle performed during the shutdown procedure of the Beckman Coulter FP1000 Cell Preparation System, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
a) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper,
12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium
Tl-6AL-4V alloy, sterile, w/calcicoat ceramic coating; Cat. no. 65-7861-14-04
(65786101404), Recall # Z-1467-06;
b) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper,
12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium TI-6AL-4V
alloy, sterile; Cat. no. 7861-14-04 (00786101404), Recall # Z-1468-06;
c) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper,
12/14 neck taper, collarless, size 15, 140 mm stem length, tivanium
TI-6AL-4V alloy, sterile; Cat. no. 7861-15-04 (00786101504), Recall # Z-1469-06;
d) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper,
12/14 neck taper, collarless, size 17, 150 mm stem length, tivanium
TI-6AL-4V alloy, sterile; Cat. no. 7861-17-04 (00786101704), Recall # Z-1470-06;
e) Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit,
collarless, 12/14 neck taper - standard body -extended neck offset,
size 14, 149 mm stem length, sterile, tivanium TI-6AL-4V alloy/tantalum,
sterile; Cat. no. 00-7864-014-20 (00786401420), Recall # Z-1471-06;
f) Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit,
collarless, 12/14 neck taper - standard body -extended neck offset,
size 15, 160 mm stem length, sterile, tivanium TI-6AL-4V alloy/tantalum,
sterile; Cat. no. 00-7864-015-20 (00786401520), Recall # Z-1472-06;
g) Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit,
collarless, 12/14 neck taper - standard body -standard neck offset, size 16,
171 mm stem length, sterile, tivanium TI-6AL-4V alloy/tantalum, sterile;
Ref. no. 00-7864-016-00 (Cat. no. 00786401600), Recall # Z-1473-06;
h) Zimmer MAYO Conservative hip prosthesis femoral stem, porous,
12/14 neck taper, large+, tivanium TI-6AL-4V alloy, sterile;
REF. 8026-13-05 (Cat. no. 00802601305), Recall # Z-1474-06;
i) Zimmer MAYO Conservative hip prosthesis femoral stem, porous,
12/14 neck taper, extra large, tivanium TI-6AL-4V alloy, sterile,
REF. 8026-14 (Cat. no. 00802601400), Recall # Z-1475-06;
j) Zimmer ZMR Hip System femoral body, revision, nitrided, porous,
12/14 neck taper, extended, 46 mm neck offset, spout body, size D,
35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9990-20-46
(Cat. no. 00999002046), Recall # Z-1476-06;
k) Zimmer ZMR Hip System femoral body, revision, nitrided, porous,
12/14 neck taper, extended, 46 mm neck offset, cone body, size C,
55 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9993-19-55
(Cat. no. 00999301955), Recall # Z-1477-06;
l) Zimmer ZMR Hip System femoral body, revision, nitrided, porous,
12/14 neck taper, standard, 40 mm neck offset, cone body, size C,
35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-35
(Cat. no. 00999601935), Recall # Z-1478-06;
m) Zimmer ZMR Hip System femoral body, revision, nitrided, porous,
12/14 neck taper, standard, 40 mm neck offset, cone body, size C,
45 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-45
(Cat. no. 00999601945), Recall # Z-1479-06;
n) Zimmer ZMR Hip System femoral body, revision, nitrided, porous,
12/14 neck taper, standard, 40 mm neck offset, cone body, size F,
35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-23-35
(Cat. no. 00999602335), Recall # Z-1480-06
CODE
a) Lot 60460460;
b) Lots 60454196, 60454197, 60454198, 60454199, 60465016 and 60465017;
c) Lots 60454201, 60454202, 60454203, 60454204, 60465019 and 60469053;
d) Lots 60454205, 60454206 and 60465024;
e) Lots 60465254 and 60469823;
f) Lots 60454312 and 60461052;
g) Lots 60454306 and 60465367;
h) Lots 60450985 and 60450986;
i) Lot 60460474;
j) Lot 60465192;
k) Lot 60465195;
l) Lot 60454259;
m) Lot 60451050;
n) Lot 60460936
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated August 2, 2006. Firm initiated recall is ongoing.
REASON
Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
VOLUME OF PRODUCT IN COMMERCE
181 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters,
Recall # Z-1482-06;
b) Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters,
Recall # Z-1483-06
CODE
a) All lot numbers equal to or lower than: CAT 606051FX - LOT 13084977;
CAT 606051JX - LOT 13077739; CAT 606051MX - LOT 13100828;
CAT 606151FX - LOT 13095822; CAT 606151JX - LOT 13090978;
CAT 606151MX - LOT 13090976; CAT 6062310F - LOT 13090973;
CAT 6062310J - LOT 13090974; CAT 6062310M - LOT 13082015;
CAT 6062510FX - LOT 13075472; CAT 6062510JX - LOT 13090975;
CAT 6062510MX - LOT 13082020; CAT 6062511FX - LOT 13090979;
CAT 6062511JX - LOT 13090971; CAT 6062511MX - LOT 13090972;
b) All lot numbers equal to or lower than: CAT 606S152FX - LOT 13009595;
CAT 606S152JX - LOT 13010913; CAT 606S152MX - LOT 13009596;
CAT 606S155FX - LOT 13082017; CAT 606S155JX - LOT 13078245;
CAT 606S155MX - LOT 13082016; CAT 606S252FX - LOT 13064387;
CAT 606S252JX - LOT 13071036; CAT 606S252MX - LOT 13090990;
CAT 606S255FX - LOT 13084973; CAT 606S255JX - LOT 13084974;
CAT 606S255MX - LOT 13064409
RECALLING FIRM/MANUFACTURER
Cordis Neurovascular, Inc., Miami Lakes, FL, by letter on August 14, 2006. Firm initiated recall is ongoing.
REASON
Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch.
VOLUME OF PRODUCT IN COMMERCE
60,613 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Kuschall's K3/K4 Series of Manual Wheelchair, Model Airlite, Recall # Z-1486-06
CODE
0805007204, 0805040231,0805087799, 0805191275, 0805238718, 0805528869, 0805590456, 0805007205, 0805040233, 0805094654, 0805202392, 0805260264, 0805528870, 0805590458, 0805007206, 0805046010, 0805112919, 0805202409, 0805260267, 0805528879, 0805598707, 0805007207, 0805052515, 0805112920, 0805202410, 0805265355, 0805538825, 0805606638, 0805031769, 0805052531, 0805112921, 0805208212, 0805265356, 0805547691, 0805606639, 0805032072, 0805052780, 0805142288, 0805214576, 0805488915, 0805556308, 0805606650, 0805032078, 0805059713, 0805148474, 0805220731, 0805528850, 0805556313, 0805626956, 0805032082, 0805059770, 0805171786, 0805220813, 0805528852, 0805573454, 0805636805 0805032091, 0805081690, 0805171787, 0805226782, 0805528854, 0805573455, 0805636810, 0805040230, 0805087792, 0805178698, 0805226965, 0805528856, 0805590391, 0805643631, 0805643632, 0805743810, 0805793490, 0805837237, 0805871475, 0805937131, 0806309254, 0805664651, 0805743813, 0805802652, 0805845927, 0805894716, 0805969761, 0806309260 0805671759, 0805771388, 0805802878, 0805845935, 0805894890, 0805977531, 0806309261, 0805685506, 0805776512, 0805807275, 0805850343, 0805894892, 0806273105, 0806309267, 0805702791, 0805776514, 0805807278, 0805855553, 0805900539, 0806281922, 0806315127, 0805710093, 0805780848, 0805807281, 0805860047, 0805900540, 0806281924, 0806315184 0805710275, 0805784712, 0805811158, 0805865040, 0805906053, 0806303957, 0806320300, 0805716215, 0805784713, 0805815571, 0805865041, 0805922688, 0806303963, 0806326394, 0805721816, 0805784714, 0805815575, 0805871470, 0805929066, 0806303965, 0806326395, 0805738220, 0805789076, 0805815809, 0805871471, 0805937122, 0806309167, 0806338838, 0806338840, 0806372582, 0806390080, 0806415186, 0806448589, 0805771388, 0806338842, 0806372583, 0806390081, 0806415385, 0806448735, 0806350846, 0806372585, 0806390082, 0806422077, 0806455546 0806350855, 0806372614, 0806390083, 0806428328, 0806463285, 0806355566, 0806372615, 0806396466, 0806428330, 0806463289, 0806366353, 0806372616, 0806408921, 0806428344, 0806463290, 0806366354, 0806372618, 0806408928, 0806428346, 0806480052, 0806366356, 0806372620, 0806408929, 0806428563, 0806480055, 0806366544, 0806390074, 0806408930, 0806435361, 0806480070, 0806372581, 0806390075, 0806408938, 0806441968, 0806488512
RECALLING FIRM/MANUFACTURER
Recalling Firm: Invacare Corporation, ElyriaOH, by letter on or about July 20, 2006.
Manufacturer: Kuschall Ag, Witteswil, Switzerland. Firm Initiated recall is ongoing.
REASON
If the user has chosen to install optional anti-tippers on the chair, the anti-tipper as designed may not be able to bear the stress of repeated or quick loads placed on it, causing the bolt to bend or break.
VOLUME OF PRODUCT IN COMMERCE
211 wheelchairs
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Recall # Z-1451-6
CODE
Lot # 06136
RECALLING FIRM/MANUFACTURER
Hardy Media Inc Dba Hardy Diag, Santa MariaCA, by telephone on June 28, 2006. Firm initiated recall is ongoing.
REASON
This recall is being conducted due to the performance failure nearing the end of the product shelf life.
VOLUME OF PRODUCT IN COMMERCE
860 Plates
DISTRIBUTION
Nationwide and PR

______________________________
PRODUCT
7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc. Recall # Z-1452-06
CODE
Lot number 00418
RECALLING FIRM/MANUFACTURER
CryoCath Technologies Inc., Kirkland, Canada, by letter on August 4, 2006. Firm initiated recall is ongoing.
REASON
Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
TCM4 Series Monitoring System (Base Unit) Model: 391-876 (affected device), transcutaneous oxygen monitor; Compact Flash cards - Model #: 914-698 (Defective Device Component), Recall # Z-1453-06
CODE
Lot Numbers R0036 thru R0043 (inclusive)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by a Field Action memo on April 7, 2006.
Manufacturer: Radiometer Medical ApS, Akandevej 21,Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further.
VOLUME OF PRODUCT IN COMMERCE
158 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers. Part #944-025, Recall # Z-1460-06
CODE
Lot QR-02, Expiration Date: September 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by e-mail dated October 31, 2005.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete.
REASON
Calibration solution for ABL700 Blood Gas Analyzers is labeled with an incorrect bar code. The bar code identified on the Cal Solution 2 product is actually the bar code for the rinse solution.
VOLUME OF PRODUCT IN COMMERCE
638/200 ml bottles
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Regius Model 370 Digital Radiography Konica Minolta, Recall # Z-1481-06
CODE
Serial # 0729-0005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Konica Minolta Medical Imaging USA, Inc., Wayne, NJ, by telephone on July 14, 2006.
Manufacturer: Konica Minolta Medical & Graphic, Inc., Tokyo, Japan. Firm initiated recall is terminated.
REASON
A hand grip column, even though locked in position, moved downward about 3 cm while a patient was holding the hand grip for lateral exposure. When the hand grip moved down, the patient who was holding it lost his or her balance and almost fell. This problem only occurred in Japan with one system.
VOLUME OF PRODUCT IN COMMERCE
One
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________
PRODUCT
Safe Guard (fenbendazole) 20% Natural Protein Deworming Block for Beef Cattle. Type C Medicated Feed Block. 25 lb block, Recall # V-136-6
CODE
Lot number D6151004
RECALLING FIRM/MANUFACTURER
Recalling Firm: Intervet, Inc., Millsboro, DE, by telephone on July 31, 2006.
Manufacturer: Sweetlix Inc., Montgomery, AL. Firm initiated recall is ongoing.
REASON
missing back label with dosing instructions
VOLUME OF PRODUCT IN COMMERCE
320 blocks
DISTRIBUTION
IA, MT, WI, MN, IN, TN and TX

END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006

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