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U.S. Department of Health and Human Services

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Enforcement Report for August 25, 2004

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.

August 25, 2004
04-34

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Germack Pistachio Company brand Almonds in 16 oz. bags. Recall # F-342-4.
CODE
Lots 040806, 040807, 040819, 040919, 040924, 050105, 050421 and 050422.
RECALLING FIRM/MANUFACTURER
Germack Pistachio Co., Detroit, MI, by talk paper on May 25, 2004 and by letter on May 26, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Samonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
4,524 BAGS.
DISTRIBUTION
CT, FL, IL, MI, and OH.

_______________________________
PRODUCT
Smoked Salmon Whole, sold in vacumm packed units that are approximately 2 ? 2.5 lbs. each. Recall # F-343-4.
CODE
Batch # 2063, Use/Freeze By Jun 20, 2004.
RECALLING FIRM/MANUFACTURER
Catsmo Corp., Wallkill, NY, by letters dated June 11, 2004. Firm initiated recall is complete.
REASON
New York State sample analysis revealed the presence of Listeria monocytogenes in the product.
VOLUME OF PRODUCT IN COMMERCE
422 units.
DISTRIBUTION
NY and NV.

_______________________________
PRODUCT
Merlino Foods brand Raw whole almonds packaged in 5 lb. clear flexible plastic bags. Recall # F-344-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Merlino Foods, Seattle, WA, by letter on May 27, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds that were recalled by Paramount Foods due to their association with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
30/5 lb. bags.
DISTRIBUTION
WA.

_______________________________
PRODUCT
a) Pic-A-Nut brand Natural Almonds packaged in 1.75 oz.
bags; product 70207 01840. Recall # F-359-4;
b) Sunray Foods brand Cashews-Almonds-Raisins Mix
Packaged in 2.75 oz. bags; product 70207 01725.
Recall # F-360-4;
c) Sunray Foods brand Energy Mix packaged in 2.75 oz.
bags, Product 70207 01708; Recall # F-361-4;
d) Sunray Foods brand Fruity Nut Mix, packaged in 2.75
oz. bags; Product 70207 01733. Recall # F-362-4;
e) Sunray Foods brand Nutty Mix, packaged in 2.75
oz. bags; Product 70207 01735. Recall # F-363-4;
f) Sunray Foods brand Fitness Mix, packaged in 2.75
oz. bags; Product 70207 01702. Recall # F-364-4;
CODE
The best before/code date of 8-04-04 through 5-31-05.
RECALLING FIRM/MANUFACTURER
Variety Foods, Inc., Warren, MI, by press release on May 25, 2004. Firm initiated the recall is complete.
REASON
The product was manufactured using almonds that were recalled by Paramount Foods due to their association with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
The firm manufactured and shipped 559 dozen bags of the 6 varieties of products containing raw whole almonds.
DISTRIBUTION
IN, MI, and OH.

_______________________________
PRODUCT
New England Smoked Seafood, Inc., Chef Noel?s Applewood Smoked Mussels Vermont Made, Net Wt. 4 0z. vacuum packed. Recall # F-368-4.
CODE
Best if Used By dates of June 16, 2004 through September 10, 2004.
RECALLING FIRM/MANUFACTURER
New England Smoked Seafood, Rutland, VT, by telephone on July 6, 2004 and by fax on July 9, 2004. Firm initiated recall is complete.
REASON
The product was contaminated with Listeria monocytogenes based on the New York State Department of Agriculture & Markets? analysis.
VOLUME OF PRODUCT IN COMMERCE
65 cases (6/case)
DISTRIBUTION
CT, MA, NH, NJ, NY, PA, VT.

_______________________________
PRODUCT
a) Almonds, natural raw in 5 lb. plastic bags,
Recall # F-374-4;
b) Swiss Trail Mix in 20 lb. bags, Item #51491.
Recall # F-375-4;
c) California Mix in 10 lb. and 30 lb. plastic bags;
Items 24472 and 42171. Recall # F-376-4;
d) High Energy Mix in 10 lb. plastic bags; Item
24541.10lb. Recall # F-377-4;
e) Amish Trail Mix in 20 lb. plastic bags. Item
65451.20 lb. Recall # F-378-4;
f) Energy Plus Trail Mix in 20 lb. plastic bags.
Item 51451.20 lb. Recall # F-379-4;
CODE
a) Lots 1143, 1275 and 1473;
b) Lot 1621;
c) 10-lb. bags - lots 1241, 1542, 1605, 1606, and 1607; 30-lb. bags ?
lots 1646 and 1611;
d) Lot 1463;
e) Lot 1445;
f) Lots 1251, 1453 and 1612;
RECALLING FIRM/MANUFACTURER
National Bulk Food Dist., Inc., Taylor, MI, by press release on May 25, 2004 and by letter beginning on May 27, 2004. Firm initiated recall is complete.
REASON
The products were manufactured using almonds that were recalled by Paramount Foods due to their association with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
6,680 pounds.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Almonds Whole Natural. Product is packed in clear rectangular rigid plastic containers and is sold by weight (approx.0.75 lbs per pack). Product is also sold via self service gravity-feed bulk bins. Recall # F-380-4.
CODE
?Sell by? dates - 11/7/2003 through 08/21/2004.
RECALLING FIRM/MANUFACTURER
Harry?s Farmers Market, Roswell, GA, by telephone and email on May 24, 2004 and by press release on May 28, 2004. Firm initiated recall is ongoing.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
31,484 lbs.
DISTRIBUTION
GA, NC and SC.

_______________________________
PRODUCT
Parker Praline Pecans-K 1054, 30 pounds Net Wt, 04030. Recall # F-381-4.
CODE
Lot number 04030.
RECALLING FIRM/MANUFACTURER
Parker Products, Inc., Fort Worth, TX, by letter on June 15, 2004. Firm initiated recall is ongoing.
REASON
Packages labeled as Praline Pecans actually contained Praline Peanuts.
VOLUME OF PRODUCT IN COMMERCE
161 cases.
DISTRIBUTION
OR and TX.

_______________________________
PRODUCT
Shelled Almonds, 25 lbs. net. Regina brand. Recall # F-382-4.
CODE
Item Code 60280.
RECALLING FIRM/MANUFACTURER
Sahadi Fine Foods, Inc., Brooklyn, NY, by press release on June 10, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide and Internationally.

 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
a) Levoxyl Tablets, (Levothyroxine Sodium Tablets) USP,
50mcg, 100 tablet bottles, Rx only. NDC 5260-4505-01;
Recall # D-234-4;
b) Levoxyl Tablets, (Levothyroxine Sodium Tablets) USP,
100mcg, 100 tablet bottles, Rx only. NDC 5260-4510-01;
Recall # D-235-4;
c) Levoxyl Tablets, (Levothyroxine Sodium Tablets) USP,
150mcg, 100 tablet bottles, Rx only. NDC 5260-4515-01;
Recall # D-236-4;
d) Levoxyl Tablets, (Levothyroxine Sodium Tablets) USP,
200mcg, 100 tablet bottles, Rx only. NDC 5260-4520-01;
Recall # D-237-4.
CODE
a) Lot #030655, Expiration Date: May 31, 04;
b) Lot #030947, Expiration Date: JUL 31, 04;
c) Lot Numbers: 030656 and 031775, Expiration Date: JUL 31,
04;
d) Lot Numbers: 030348, 030654, 030704 and 031057,
Expiration Date: JUL 31, 04.
RECALLING FIRM/MANUFACTURER
Amerisource Health Services Corp., Columbus, OH, by letter and fax on July 7, 2004. Firm initiated recall is complete.
REASON
Subpotent (Stability).
VOLUME OF PRODUCT IN COMMERCE
41,371 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Member's Mark®, Pain Reliever, Fever Reducer, Acetaminophen 500 mg, Non Aspirin Extra Strength, 500 Caplets. Recall # D-241-4.
CODE
Bulk Code BA0078AC, Lot Number: 3KB0745A.
RECALLING FIRM/MANUFACTURER
Leiner Health Products, Carson, CA, by letter on July 21, 2004. Firm initiated recall is ongoing.
REASON
Presence of foreign substance.
VOLUME OF PRODUCT IN COMMERCE
29,760 bottles, 500 count bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Children's Motrin Tablets (Ibuprofen), 50 mg, 24 Grape-Flavored Chewable Tablets, Pain Reliever/Fever Reducer, over-the-counter. Recall # D-245-4.
CODE
Lot number and expiration dates, respectively, JBM074 exp. 02/06; HSM192, exp 01/06; JBM006 exp. 02/06.
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil-PPC, Inc., Fort Washington, PA, by letter on June 7, 2004. Firm initiated recall is ongoing.
REASON
Mislabeling, printing defect on carton label dosing chart for ages 4-5 may incorrectly indicate 8 tablets instead of 3 tablets. Note: bottle label correctly indicates 3 tablets.
VOLUME OF PRODUCT IN COMMERCE
172,080 bottles of 24 tablets.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Diprivan (propofol) 1% Injectable Emulsion, 10mg/ml, 100 ml Vial, For IV administration, Sterile, Nonpyrogenic. Recall # D-246-4.
CODE
Lot Number 4429J, expiration July 2005.
RECALLING FIRM/MANUFACTURER
AstraZeneca Pharmaceuticals Lp, Newark, NJ, by letter on May 24, 2004. Firm initiated recall is ongoing.
REASON
Presence of particulate matter.
VOLUME OF PRODUCT IN COMMERCE
11,234 vials.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Risperdal (Risperidone) Tablets, 3 mg, 60 count bottles, Rx only. NDC 50458-33006. Recall # D-251-4.
CODE
Lot 3NG583, exp 11/05; Lot 4AG756, exp. 12/05.
RECALLING FIRM/MANUFACTURER
Top Rx, Bartlett, TN, by fax and letter on May 4, 2004. Firm initiated recall is ongoing.
REASON
Adulterated; Presence of Foreign Tablets.
VOLUME OF PRODUCT IN COMMERCE
10 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Abilify Tablets (aripiprazole), 5 mg, 30 count bottles,
Rx only. NDC 59148-007-13. Recall # D-254-4;
b) Abilify Tablets (aripiprazole), 10 mg, 30 count bottles,
Rx only. NDC 59148-008-13. Recall # D-255-4;
c) Abilify Tablets (aripiprazole), 15 mg, 30 count bottles,
Rx only. NDC 59148-009-13. Recall # D-256-4;
d) Abilify Tablets (aripiprazole), 20 mg, 30 count bottles,
Rx only. NDC 59148-010-13. Recall # D-257-4;
e) Abilify Tablets (aripiprazole), 30 mg, 30 count bottles,
Rx only. NDC 59148-011-13. Recall # D-258-4;
CODE
a) Lot no. 3H65463;
b) Lot no. 3H65464;
c) Lot no. 3H65465;
d) Lot no. 3H65466 and 4D83127;
e) Lot no. 3H65467.
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Company, New Brunswick, NJ, by letters on June 26, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure (9 month stability).
VOLUME OF PRODUCT IN COMMERCE
301,965 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
ESTRACE Tablets, (estradiol tablets, USP), 1mg, 100 tablets, Rx only. NDC 0430-0023-24. Recall # D-261-4.
CODE
Lot 4A79546 exp. 1/07.
RECALLING FIRM/MANUFACTURER
Warner Chilcott Labs, Rockaway, NJ, by letters on June 4, 2004. Firm initiated recall is ongoing.
REASON
Mislabeling: Outer carton incorrectly states contains 0.5mg estradiol whereas the bottle label correctly states contains 1.Omg estradiol.
VOLUME OF PRODUCT IN COMMERCE
2,348 bottles.
DISTRIBUTION
Nationwide.

 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Amiodarone Hydrochloride Injection, 900 mg/18mL (50mg/ml) For IV use only, Rx only. Recall # D-233-4.
CODE
Lot # 494974 ? Exp. Date: 09/2005;
Lot # 450492 and # 450492A, Exp. Date: 03/2005;
Lot # 475953 and # 475953A, Exp. Date: 03/2005.
RECALLING FIRM/MANUFACTURER
Bedford Laboratories, Bedford, OH, by letter on June 16, 2004 and June 29, 2004. Firm initiated recall is ongoing.
REASON
Presence of particulate matter.
VOLUME OF PRODUCT IN COMMERCE
85,727 vials.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Phenytek, brand of Phenytoin Sodium, USP 200 mg and 300
mg, extended release capsules. Labeled in part
***Physician Sample. Not to be sold. Rx only***.
Packaged in bottles of 7, 10, and 30 capsules. Recall #
D238-4;
b) Kristalose brand of Lactulose, 10 mg and 20 mg single
dose packets, for oral solution. Rx only. Packaged in
boxes of 30 packets. Recall # D-239-4;
c) Avita brand of Tretinoin Gel 0.025%, 2 gm tubes, for
topical use only. Product labeled in part ***Physician
Sample*** Rx only***. Recall # D240-4.
CODE
a) Lots: 2J2662 exp 8/31/2003 1K0076 exp 1/31/2004 1K0077
exp 1/31/2004 2J2666 exp 8/31/2004 1K0083 exp 1/31/2004
1K0084 exp 1/31/2004 1K0085 exp 1/31/2004;
b) Lots: S03060 exp 11/30/03 S02060 exp 11/30/03 S19050 exp
11/30/03 S01090 exp 11/30/03 S13070 exp 10/31/03 S11070
exp 10/31/03 S14070 exp 11/30/03;
c) Lot RFMM exp 11/30/02.
RECALLING FIRM/MANUFACTURER
Bertek Pharmaceuticals, Inc., RTP, NC, by telephone and fax on March 2, 2004. Firm initiated recall is complete.
REASON
Pharmaceuticals were distributed to physician offices beyond the labeled expiration date of the products.
VOLUME OF PRODUCT IN COMMERCE
13,586 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Amitriptyline HC1, 10mg, 100 and 1000 count bottles, Rx only, NDC #0603-2212-32 and NDC # 0603-2212-21. Recall # D-242-4.
CODE
Lot #T018H03 and T019H03, exp. Date 08/05.
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals Llc, by letters dated June 25, 2004. Firm initiated recall is ongoing.
REASON
Impurities: impurity level exceeded at the 9 month stability point.
VOLUME OF PRODUCT IN COMMERCE
4,697 bottles of 1000 and 45,435 bottles of 100.
DISTRIBUTION
Nationwide.

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1549-4;
b) Red Blood Cells, Leukoreduced. Recall # B-1550-4;
c) Recovered Plasma. Recall # B-1551-4.
CODE
a) Units: 5144299, 5175529;
b) Units: 5169754, 5199222;
c) Units: 5144299, 5175529, 5169754, 5199222.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by fax dated August 26, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis who was incorrectly removed from the deferral list, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
TX, TN, Italy and Switzerland.

_______________________________
PRODUCT

Red Blood Cells, Leukocytes Reduced. Recall # B-1667-4;                     
Platelets, Leukocytes Reduced. Recall # B-1668-4.
CODE
a) Units (3 units) LE63225, LE72919 (split 1 and split 2);
b) Unit (1 unit) LE63225.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., DBA Rhode Island Blood Center,
Providence, RI, by letter dated April 27, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
RI.

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1720-4.
CODE
Unit 29KL33368.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone and letter on February 26, 2004. Firm initiated recall is complete.
REASON
Blood Products, collected from a donor who provided a history of melanoma, were distributed.
VOLUME OF PRODUCT IN COMMER
1 unit.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1808-4.
CODE
Unit number 17GR18584.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, St Paul, MN, by letter on October 23, 2002. 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
MA.
____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1831-4.
CODE
Unit number 04KM48148.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on March 25, 2004, and April 1, 2004, and by letter on April 2, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who medical history interview was inadequately documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NH.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1832-4;
b) Fresh Frozen Plasma. Recall # B-1833-4;
c) Recovered Plasma. Recall # B-1834-4.
CODE
a) Unit numbers 04E68497 and 04E59857;
b) Unit number 04E68497;
c) Unit number 04E59857.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on April 9, 2004, by letter on April 12, 2004, and by facsimile on April 8 and 9, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose medical history interview did not have documentation to answers to the medical history questions related to risk factors for Creutzfeldt-Jacob disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
CA, MA, and NY.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1838-4.
CODE
Units 01GY80716, 01GY78653.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, American Red Cross Blood Services, New York - Penn Region, West Henrietta, NY, by facsimile on August 25, 2003, September 15, 2003 and September 25, 2003, and by telephone on August 5, 2004.
Manufacturing Firm: ARC Biomedical Services (NY-Penn Region), Syracuse, NY. 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
NY.

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1721-4.
CODE
Unit 29KL33368.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone and letter on February 26, 2004. Firm initiated recall is complete.
REASON
Blood Products, collected from a donor who provided a history of melanoma, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-1809-4.
CODE
Unit numbers 17201-3605 and 17201-3607.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by telephone on May 28, 2003. Firm initiated recall is complete.
REASON
Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1829-4.
CODE
Unit number 084M10550.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern California Region, Oakland, CA, by letter on August 5, 2000. Firm initiated recall is complete.
REASON
Platelets, not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced Reduced Irradiated. Recall # B-1830-4.
CODE
Unit numbers 084Q63250 and 084K08416.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern California Region, Oakland, CA, by letter on July 22, 2000. Firm initiated recall is complete.
REASON
Blood products that were possibly out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
a) Lorad M-IV Mammography System. Recall # Z-0148-04;
b) Lorad M-IV Platinum Mammography System. Recall # Z-
0149-04.
CODE
a) and b) S/N's: 18005960001 to 18010034196.
RECALLING FIRM/MANUFACTURER
Lorad, A Division of Hologic, Danbury, CT, by letter dated January 14, 2004. Firm initiated recall is complete.
REASON
System failed to meet the mA's accuracy specifications at low mA's values.
VOLUME OF PRODUCT IN COMMERCE
4,206 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Boheringer Suction Regulator Model 7702L.
Recall # Z-1231-04;
b) Boehringer Replacement Gauge Model 9071.
Recall # Z-1232-04.
CODE
a) Lot number 04D;
b) Lot number 200405.
RECALLING FIRM/MANUFACTURER
Boehringer Laboratories, Inc., Norristown, PA, by telephone on May 19, 2004. Firm initiated recall is ongoing.
REASON
The suction regulator incorporates a gauge for the verification of suction levels. The particular lot of gauges used in the production of the regulators exhibits a potential to develop a leak and cause the delivered suction to be inaccurate.
VOLUME OF PRODUCT IN COMMERCE
56 units.
DISTRIBUTION
AL, FL, MA, MI, OR, PA, and TN.
______________________________
PRODUCT
a) 3 Series Full Body Phototherapy Device with Smart Touch
Control System, Model #PASNBSM-2424. Recall # Z-1233-04;
b) 3 Series Full Body Phototherapy Device with Smart Touch
Control System, Model #ASNBSM-2424. Recall # Z-1234-04;
c) 3 Series Full Body Phototherapy Device with Smart Touch
Control System, Model #LNBH-0048. Recall # Z-1235-04;
d) 3 Series Full Body Phototherapy Device with Smart Touch
Control System, Model #SNBSM-0048. Recall # Z-1236-04;
e) 3 Series Full Body Phototherapy Device with Smart Touch
Control System, Model #ANBSM-0048. Recall # Z-1237-04.
CODE
All Touch Control System units manufactured between 6/5/03 and 4/30/04.
RECALLING FIRM/MANUFACTURER
Daavlin Distributing Co., Bryan, OH, by service representative visit beginning on September 1, 2003. Firm initiated recall is ongoing.
REASON
Software errors cause the unit to not deliver the prescribed therapy and do not allow the patient records to be saved.
VOLUME OF PRODUCT IN COMMERCE
68 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Smiths Medical ASD, Inc, Regional Anesthesia Trays containing the Hospira 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) as follows: Product Number/Description 15248C-22/25 SPINAL TRAY 22/25 (SDD) W/DRUGS. Recall # Z-1240-04;
b) 15249-21 SPINAL (DD) 22/25G QUINCKE W/DRUGS. Recall # Z-1241-04;
c) 15524-20 SPINAL (DD) 22G QUINCKE 25G DIAMOND POINT W/DRUGS. Recall # Z-1242-04;
d) 15545-20 SPINAL(DD) 25G W/DRUGS. Recall # Z-1243-04;
e) 15545-21 SPINAL(DD) 25G W/DRUGS. Recall # Z-1244-04;
f) 15548-20 REG ANES W/DRUGS. Recall # Z-1245-04;
g) 15551-20 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-1246-04;
h) 15568-20 SPINAL(DD) 25G W/DRUGS. Recall # Z-1247-04;
i) 15574-20 SPINAL(DD) 25G WHITACRE. Recall # Z-1248-04;
j) 15583-21 SPINAL(DD) 24G EUROPEAN PENCIL POINT W/DRUGS. Recall # Z-1249-04;
k) 15594-21 SPINAL(DD) 24G EUROPEAN PENCIL POINT W/DRUGS. Recall # Z-1250-04;
l) 15597-20 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-1251-04;
m) 15626-21 SPINAL(DD) 22/25G W/DRUGS. Recall # Z-1252-04;
n) 15646-20 SPINAL(DD) 27G WHITACRE W/DRUGS. Recall # Z-1253-04;
o) 15648-21 SPINAL(DD) 22G WHITACRE W/DRUGS. Recall # Z-1254-04;
p) 15667-20 SPINAL(DD) 26G QUINCKE W/DRUGS. Recall # Z-1255-04;
q) 15674-20 SPINAL(DD) 22/24G W/DRUGS. Recall # Z-1256-04;
r) 15711-20 SPINAL(DD) 27G QUINCKE W/DRUGS. Recall # Z-1257-04;
s) 15776-20 REG ANES W/DRUGS. Recall # Z-1258-04;
t) 15810-21 SPINAL(DD) 24G SPROTTE W/DRUGS. Recall # Z-1259-04;
u) 15816-21 SPINAL(DD) 27G QUINCKE W/DRUGS. Recall # Z-1260-04;
v) 15830-21 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-1261-04;
w) 15848-20 SPINAL(DD) 24G SPROTTE W/DRUGS. Recall # Z-1262-04;
x) 15876-20 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-1263-04;
y) 15955-21 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-1264-04;
z) 15961-20 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-1265-04;
aa) 15963-20 SPINAL(DD) 22G WHITACRE W/DRUGS. Recall # Z-
1266-04;
bb) 15973-21 SPINAL(DD) 25G WHITACRE W/DRUGS. Recall # Z-
1267-04;
cc) 15995-20 SPINAL(SDD) 25G QUINCKE W/DRUGS. Recall # Z-
1268-04;
dd) 4745-20 SADDLE BLOCK 26G W/DRUGS. Recall # Z-1269-04;
ee) 4792-20 SADDLE BLOCK 22G W/DRUGS. Recall # Z-1270-04;
ff) 4795-21 SADDLE BLOCK 25G QUINCKE W/DRUGS. Recall # Z-
1271-04;
gg) 4804-20 SPINAL(DD) 22G WHITACRE W/DRUGS. Recall # Z-
1272-04;
hh) 49651-22 SPINAL 22G PENCIL POINT W/DRUGS. Recall # Z-
1273-04;
ii) 49651-24 SPINAL 24G EUROPEAN PENCIL POINT W/DRUGS.
Recall # Z- 1274-04;
jj) 49651-25 SPINAL 25G PENCIL POINT W/DRUGS. Recall # Z-
1275-04;
kk) 49651-27 SPINAL 27G PENCIL POINT W/DRUGS. Recall # Z-
1276-04;
ll) 49652-25 SPINAL 25G PENCIL POINT W/DRUGS. Recall # Z-
1277-04;
mm) 4965-25 SPINAL(SHB) WHITACRE W/DRUGS. Recall # Z-
1278-04;
nn) A1645-25 SPINAL(FL) WHITACRE W/DRUGS. Recall # Z-
1279-04;
oo) A2152-25 SPINAL(FL) WHITACRE W/DRUGS. Recall # Z-
1280-04;
pp) A2291-27 SPINAL(SDD) W/DRUGS. Recall # Z-1281-04;
qq) A2526-24 SPINAL(SHB) W/DRUGS. Recall # Z-1282-04;
rr) A2527-27 SPINAL(SHB) W/DRUGS. Recall # Z-1283-04;
ss) A2613 SPINAL(FL) W/DRUGS. Recall # Z-1284-04;
tt) A2624-22/25 SPINAL(SDD) W/DRUGS. Recall # Z-1285-04;
uu) A2654-24 SPINAL(FL) W/DRUGS. Recall # Z-1286-04;
vv) A2675-25 SPINAL(SHB) W/DRUGS. Recall # Z-1287-04;
ww) A2705-26 SPINAL(SHB) W/DRUGS. Recall # Z-1288-04;
xx) A2814 SPINAL(SDD) W/DRUGS. Recall # Z-1289-04;
yy) A2832-25 SPINAL TRAY(SDD) W/DRUGS. Recall # Z-1290-04;
zz) A2837 SPINAL(SDD) W/DRUGS. Recall # Z-1291-04;
aaa) A2957 SPINAL(SDD) W/DRUGS K516566. Recall # Z-1292-04.
bbb) A2971-25 SPINAL(SHB) W/DRUGS. Recall # Z-1293-04;
ccc) A33015-25 SPINAL(SDD) W/DRUGS. Recall # Z-1294-04;
ddd) A3065-25 SPINAL TRAY (SDD) W/DRUGS. Recall #Z-1295-04;
eee) A3075-25 SPINAL(SDD) W/DRUGS. Recall # Z-1296-04;
fff) A3077-25 SPINAL(SDD) W/DRUGS. Recall # Z-1297-04;
ggg) A3121-25 SPINAL(SDD) W/DRUGS. Recall # Z-1298-04;
hhh) 4795-20 SADDLE BLOCK 25G QUINCKE W/DRUGS. Recall # Z-1299-04.
CODE
a) Lot Number: K521049;
b) Lot Number: K516849;
c) Lot Number: K515994;
d) Lot Numbers: K514753, K515420, K519328;
e) Lot Numbers: K518658, K519342, K522288;
f) Lot Number: K518637;
g) Lot Numbers: K517594, K519340;
h) Lot Numbers: K522290, K523226;
i) Lot Number: K521821;
j) Lot Number: K514766;
k) Lot Number: K516549;
l) Lot Numbers: K516577, K518660, K518947, K519334;
m) Lot Number: K516650;
n) Lot Number: K517586;
0) Lot Number: K516540;
p) Lot Number: K521706;
q) Lot Numbers: K516051, K521791;
r) Lot Number: K521793;
s) Lot Number: K516572;
t) Lot Number: K519319;
u) Lot Number: K516574;
v) Lot Number: K516550;
w) Lot Number: K521691;
x) Lot Numbers: K518603, K520640, K522835;
y) Lot Number: K516575;
z) Lot Number: K516570;
aa) Lot Number: K519322;
bb) Lot Number: K517096;
cc) Lot Number: K518621;
dd) Lot Number: K521800;
ee) Lot Number: K517590;
ff) Lot Number: K517583;
gg) Lot Number: K519326;
hh) Lot Number: K517129;
ii) Lot Number: K518190;
jj) Lot Numbers: K515853, K517107, K518986, K522227;
kk) Lot Number: K515837;
ll) Lot Numbers: K517112, K522257;
mm) Lot Numbers: K515841, K518985, K520198;
nn) Lot Number: K515828;
oo) Lot Number: K515816;
pp) Lot Number: K518632;
qq) Lot Numbers: K516347, K520553, K522055;
rr) Lot Number: K520552;
ss) Lot Numbers: K515876, K520197, K522302;
tt) Lot Number: K516579;
uu) Lot Number: K515869;
vv) Lot Number: K515838;
ww) Lot Numbers: K515877, K522291;
xx) Lot Number: K521066;
yy) Lot Numbers: K518630, K521080;
zz) Lot Number: K521789;
aaa) Lot Number: K516566;
bbb) Lot Number: K519197;
ccc) Lot Numbers: K517099, K521073, K521413;
ddd) Lot Number: K516053;
eee) Lot Number: K516535;
fff) Lot Numbers: K516531, K521703;
ggg) Lot Number: K518587;
hhh) Lot Numbers: K518662, K521823.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Keene, NH, by letter on July 2, 2004. Firm initiated recall is ongoing.
REASON
Trays contain Hospira recalled, 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK).
VOLUME OF PRODUCT IN COMMERCE
72,180 trays.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). a) Cat. #60-5158-034 ? Spatula;
b) Cat. #60-5158-234 ? ?J? Hook;
c) Cat. #60-5158-432 ? ?L? Hook;
d) Cat. #60-5158-934 ? Needle. Recall # Z-1301-04.
CODE
a) Lot #s 0310301, 0402031, 0403051, 0404131;
b) Lot # 0310081;
c) Lot #s 0310081, 0310301, 0311101, 0401051, 0401121,
0402031, 0403051, 0411121;
d) Lot #s 0311101, 0401121.
RECALLING FIRM/MANUFACTURER
Conmed Corporation, Utica, NY, by letters dated June 28, 2004. Firm initiated recall is ongoing.
REASON
Insulation of some electrodes may have pulled away from the hub of the electrode exposing the conductive shaft below.
VOLUME OF PRODUCT IN COMMERCE
3,252 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Roche brand Reflotron GOT (AST), 30 test strips;
catalog # 745120. Recall # Z-1302.04;
b) Roche brand Reflotron GPT (ALT), 30 test strips;
catalog # 745138. Recall # Z-1303.04
CODE
a) Lots 23665132, exp 5/31/2005; and 23665231, exp
6/30/2005;
b) Lot 23717132; exp 5/31/2005.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letters dated July 14, 2004. Firm initiated recall is ongoing.
REASON
Coating defect may result is falsely decreased patient and/or control results.
VOLUME OF PRODUCT IN COMMERCE
363 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Achillon? minimally invasive Achilles tendon suture system. Recall # Z-1304-04.
CODE
Achillon Reference No.: 119 700, Batch No. C Sterilization Batch No.: S037.
RECALLING FIRM/MANUFACTURER
Wright Medical Technology Inc., Arlington, TN, by email and telephone on July 6, 2004. Firm initiated recall is ongoing.
REASON
Lack of sterility assurance.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
Nationwide.
____________________________
PRODUCT
Berichrom Heparin Reagent (OWLD1l). The reagent is a component in a test kit. Recall # Z-1305-04.
CODE
Lots 541428, 541429, espiration date of Nov 2006.
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE, by letter on June 7, 2004. Firm initiated recall is ongoing.
REASON
Customers have reported a high rate of instrument error flags and calibration issues when using affected reagent.
VOLUME OF PRODUCT IN COMMERCE
781 kits.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options. Recall # Z-1332-04.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Advanced Bionics Corporation, Sylmar, CA, by letters on July 27, 3004. Firm initiated recall is ongoing.
REASON
Battery pack may overheat and cause patient burns.
VOLUME OF PRODUCT IN COMMERCE
2,458 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Welch Allyn Vital Signs Monitor 5300, Series 300, Part numbers 007-0098-00 through 007-0159-00. Recall # Z-1333-04.
CODE
Serial numbers JA000225 through JA002052.
RECALLING FIRM/MANUFACTURER
Welch Allyn Protocol, Inc., Beaverton, OR, by letters dated June 8, 2004 through July 9, 2004. Firm initiated recall is ongoing.
REASON
Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.
VOLUME OF PRODUCT IN COMMERCE
1,828 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Digital Radiography System, Model DFP-8000D. Recall # Z-1337-04.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Toshiba American Med Sys. Inc., Tustin, CA, by letter on June 24, 2004. Firm initiated recall is ongoing.
REASON
Defect in the mirroring unit. Unloading and loading of the disk head is scheduled about 12 hours after the power-on to prevent a failure if the read/write head remains in one position over an extended period. If a write operation is requested during the operationdescribed above, the data will not be written to the disk. When the error occurs, the DFP-8000D displays an error message and it may become impossible to acquire images. The data unwritten into disk may prevent the DFP-8000D from the recovery by rebotting.
VOLUME OF PRODUCT IN COMMERCE
19 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Accura System for Blood Filtration, a) product codes 5M5660 and b) ACCURA01 (international); a hemofiltration system. Recall # Z-1338-04.
CODE
a) Serial numbers 551-556, 569, 570, 582-587, 600-604, 623, 628, 649, 650, 656-658, 667-670, 677, 685-688, 695-697, 709-712, 719-722, 729, 730, 732, 740, 741;
b) Serial numbers 519, 520, 532-534, 536-541, 550, 557-560, 571-574, 579-581, 588, 589, 599, 617, 659-661, 676, 678, 679.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letter dated July 26, 2004. Firm initiated recall is ongoing.
REASON
The Accura machine display screen may go blank during patient treatment. There is a potential risk to the patient in that the operator may try to manipulate the controls in response to a blank screen, which could affect the current patient?s treatment.
VOLUME OF PRODUCT IN COMMERCE
85 units.
DISTRIBUTION
Nationwide and Internationally.

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Arrow Epidural Catheterization Kit. Product No. MC-05001. Recall # Z-1300-04.
CODE
Lot No. RF4044686, expiration date 2006-09.
RECALLING FIRM/MANUFACTURER
Arrow International Inc., Reading, PA, by letter on June 7, 2004. Firm initiated recall is ongoing.
REASON
The recall is due to a confirmed packaging error of the wrong length epidural needle (longer than stated), date 2006-09.
VOLUME OF PRODUCT IN COMMERCE
270 units.
DISTRIBUTION
TN and TX.

_______________________________
PRODUCT
Pacific Hemostasis D-Dimer Assay Kit, Fisher Diagnostics Catalog Number 100660, packaged in a cardboard box containing materials and reagents to perform 80 tests. Recall # Z-1336-04.
CODE
Lot 660-926 exp 10/31/04; Lot 660-927 exp 09/30/04; Lot 660-928 exp 11/30/04; Lot 660-929 exp 06/30/05; Lot 660-930 exp 03/31/05.
RECALLING FIRM/MANUFACTURER
Fisher Diagnostic, A Company of Fisher Scientific LLC, Middletown, VA, by letter on July 1, 2004. Firm initiated recall is ongoing.
REASON
Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samplels.
VOLUME OF PRODUCT IN COMMERCE
4,682 kits.
DISTRIBUTION
Nationwide and Internationally.

END OF ENFORCEMENT REPORT FOR AUGUST 25, 2004

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