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U.S. Department of Health and Human Services

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Enforcement Report for September 22, 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.

September 22, 2004
04-38

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Mi Costenita Almendra Natural Almond, packaged in 1-1/2 oz. plastic bags/12 bags per case. Item 200, UPC 14444-00200. Recall # F-435-4.
CODE
The cases are marked with the week of production, i.e. week #15 (packaged in April 2004) in various colors to denote the month, i.e. green for April.
RECALLING FIRM/MANUFACTURER
Yoli, Inc. dba Mi Costenita, Chicago, IL, by letters beginning on August 5, 2004. Firm initiated recall is complete.
REASON
The product was manufactured with raw almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
2,266 cases.
DISTRIBUTION
IL, GA, NC, MN, TX, NE, AR, WI, and IN.

_______________________________
PRODUCT
Raw Almonds packed in 5 lb., 10 lb., and 25 lb. boxes. The almonds are weighed and packaged, and the weight and price are hand-written on each label. Recall # F-436-4.
CODE
Product is not coded.
RECALLING FIRM/MANUFACTURER
Royal Food Int’L Corp, Long Island City, NY, by letters dated June 10, 2004, and press release on June 16, 2004. Firm initiated recall is complete.
REASON
The almonds were repackaged from bulk raw almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
NY, NJ and CT.

_______________________________
PRODUCT
Product is packed in a clear plastic clam shell container with a top label reading Dutch Apple Pie and the bottom has an incorrect label for Strawberry Rhubard pie. The top label also states NET WT. 28 oz (1 lb. 12 oz.) 784 g 8-inch Pie. Recall # F-437-4.
CODE
All Dutch Apple pies with store expiration lot numbers that are mislabeled with the bottom Strawberry Rhubard pie ingredient label. Frozen pies still in the cases at the stores and are not displayed for sale have the expiration/or number of 10-2-04 on the cases.
RECALLING FIRM/MANUFACTURER
Publix Super Markets, Inc., Lakeland, FL, by letter on April 16, 2004 and by press release on April 22, 2004. Firm initiated recall is ongoing.
REASON
Baked ready to serve Dutch Apple pies have undeclared milk allergens because of incorrect ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
3,450 pies.
DISTRIBUTION
GA, TN, AL and SC.

_______________________________
PRODUCT
a) Fruit and Nut Trail Mix Granola Bars, multiple retail
chain brands, packaged in 7.4 oz. boxes.
Recall # F-438-4;
b) Muesli Cereal, multiple retail chain brands, in a 15.3
oz. box. Recall # F-439-4.
CODE
a) Expiration dates between June 6, 2004 (JUN0604) and
Jan 20, 2005 (JAN2005) to include: JUN0604 JUN1004
JUN1504 JUN1604 JUN1704 JUN1804 JUN1904 JUN2004
JUN2104 JUL0504 JUL0604 JUL0804 JUL0904 JUL2204
JUL2304 JUL2104 SEP1004 SEP1104 OCT2704 OCT2804
OCT2604 NOV1204 NOV1304 NOV0304 DEC2104 DEC2204
DEC2304 DEC3104 DEC2404 DEC1504 JAN1905 JAN2005;
b) Expiration dates between September 10, 2004 (SEP1004)
and December 10, 2004 (DEC1004) to include: SEP1004
SEP2604 SEP2804 SEP3004 OCT0104 OCT1204 OCT2204
OCT2604 DEC1004.
RECALLING FIRM/MANUFACTURER
Con Agra Store Brands, Lakeville, MN, by press release, letter, telefax, telephone, e-mail, or visit beginning on July 9, 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
161,332 cases of bars and 50,491 cases of cereal.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
La Quinta Raw Whole Almonds, packaged in 5 lb. Plastic bags. Recall # F-440-4.
CODE
All product shipped between April 12, 2004 and June 30, 2004 is subject to the recall.
RECALLING FIRM/MANUFACTURER
La Quinta Food Products, Chicago, IL, by telephone on June 29, 2004. Firm initiated recall is ongoing.
REASON
The products were manufactured with raw almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
40 lbs.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Cablanca Goat’s Cheese, 100 % Goat’s Milk***Holland. Product is sold in bulk wheels of approximately 9 lbs. Each, and in retail packages weighing approx. 7-9 oz. each. Recall # F-441-4.
CODE
All codes on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Jana Foods, Llc, Secaucus, NJ, by letters on June 1, 2004 and press release on July 30, 2004. Firm initiated recall is ongoing.
REASON
The goat cheese contains undeclared egg white lysozyme.
VOLUME OF PRODUCT IN COMMERCE
2,446 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Nabisco 100 Calorie Packs Oreo Thin Crisps Baked Chocolate Wafer Snacks, 4.86 oz. cartons containing six individual serving bags. Recall # F-444-4.
CODE
08 JAN 05 CD and 10 JAN 05 CD.
RECALLING FIRM/MANUFACTURER
Kraft, Inc., Northfield, IL, by press release on August 12, 2004. Firm initiated recall is ongoing.
REASON
The cartons identified as 100 Calorie Packs Oreo Thin Crisps Baked Chocolate Wafer Snacks contain six bags of 100 Calorie Packs Chips Ahoy! Thin Crisps Baked Chocolate Chip Snacks, which contain milk.
VOLUME OF PRODUCT IN COMMERCE
1,944 cases.
DISTRIBUTION
IA, and IL.

_______________________________
PRODUCT
BINGHAM HILL RUSTIC BLUE hand crafted Colorado cheese. Product is sold as 5 pound whole wheels from the manufacturer, and may also be sold in smaller portions (6-8 oz wedges) packaged in plastic. Recall # F-452-4.
CODE
Lot #’s: BL04-063; BL04-041; BL04-055; BL04-069; and BL04-090.
RECALLING FIRM/MANUFACTURER
Bingham Hill Cheese Company, Fort Collins, CO, by letter and telephone on September 12, 2003 and September 29, 2003. Firm initiated recall is complete.
REASON
FDA analysis found the cheese to contain Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
360 pounds (72 whole wedges).
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Kick Start, High Energy Sparking Glucose Drink, 1 liter. The product is shipped in cartons of 12 units. The units are shrink wrapped in plastic. Recall # F-434-4.
CODE
3113 12:22 8/8 23 APR 04.
RECALLING FIRM/MANUFACTURER
McElroy Imports, Glen Mills, PA, by telephone on June 17, 2004. Firm initiated recall is complete.
REASON
The product contained the color sunset yellow FCF (certifiable as FD&C Yellow #6).
VOLUME OF PRODUCT IN COMMERCE
50 cases.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Ground Reese’s Pieces. The candies are packaged in 10 lb & 25 lb boxes. Recall # F-445-4.
CODE
All products manufactured prior to 7/29/04.
RECALLING FIRM/MANUFACTURER
Erie Island Foods, Inc., Elmore, OH, by visit beginning on August 2, 2004. Firm initiated recall is ongoing.
REASON
The product contains undeclared colors, Yellow #6, Red #40 & Blue #1.
VOLUME OF PRODUCT IN COMMERCE
416 – 10 lb boxes and 4 – 15 lb boxes.
DISTRIBUTION
MI, OH, PA, IL, & GA.

_______________________________
PRODUCT
a) Pantene PRO-V shampoo Hydrating Curls, 400 mL (13.5 fl
oz.). Shampoo is packaged in a plastic bottle.
UPC 80878-00451. Recall # F-446-4;
b) Pantene PRO-V shampoo Classic Clean, 400 mL (13.5 fl
oz.). Shampoo is packaged in a plastic bottle.
UPC 80878-00452. Recall # F-447-4;
c) Pantene PRO-V shampoo Smooth & Sleek, 400 mL (13.5 fl
oz.). Shampoo is packaged in a plastic bottle.
UPC 80878-00448. Recall # F-448-4;
d) Pantene PRO-V shampoo Color Revival, 400 mL (13.5 fl
oz.). Shampoo is packaged in a plastic bottle.
UPC 80878-00449. Recall # F-449-4;
e) Pantene PRO-V shampoo Clarifying, 400 mL (13.5 fl oz.).
Shampoo is packaged in a plastic bottle.
UPC 80878-00453. Recall # F-450-4;
f) Pantene PRO-V shampoo Regular, 400 mL (13.5 fl oz.).
Shampoo is packaged in a plastic bottle. UPC 80878-
00463. Recall # F-451-4.
CODE
a) Manufacturer’s code (L) 31345395XD;
b) Manufacturer’s code (L) 31565395XH;
c), d), e) and f) Manufacturer’s code unknown.
RECALLING FIRM/MANUFACTURER
APO Health Inc., Oceanside, NY, by letter on August 13, 2004. Firm initiated recall is ongoing.
REASON
Products were contaminated with Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE
Approx. 10, 684 cases/12 bottles per case.
DISTRIBUTION
NY and OH.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
a) Hunt’s Snack Pack Family Pack Chocolate/Vanilla Variety
Pack Pudding. Package contains 12 - 3.5 oz. pudding cups
(six vanilla and 6 chocolate), Net Wt. 42 oz. Recall
# F-432-4;
b) Hunt’s Snack Pack Family Pack Fat Free Chocolate/Vanilla
Variety Pack Pudding. Package contains 12 - 3.5 oz.
pudding cups (six vanilla and 6 chocolate), Net Wt. 42 oz.
Recall # F-433-4.
CODE
a) and b) Case Production Codes: 2109 330000 (A-Z) E, 2109 330100 (A-Z) E, 2109 330200 (A-Z) E, 2109 330300 (A-Z) E, 2109 330400 (A-Z)E Selling Unit Production Codes: R3300, R3302, R3303, R3304.
RECALLING FIRM/MANUFACTURER
Conagra Foods, Irvine, CA, by telephone and letter beginning on February 20, 2004. Firm initiated recall is complete.
REASON
Product is unfit for food due to off flavor, off odor, and/or liquefied appearance. Analysis revealed microorganisms Leuconostoc argentinum and Streptococcus viridans.
VOLUME OF PRODUCT IN COMMERCE
18,152 cases regular and 28,354 cases fat free.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Breyers Fruit on the Bottom Pineapple Low Fat Yogurt,
packaged in 8 oz. plastic cups, 12 cups per case;
UPC #21000-12645. Recall # F-442-4;
b) Breyers Fruit on the Bottom Black Cherry Low Fat Yogurt,
packaged in 8 oz. plastic cups, 12 cups per case;
UPC #21000-12644; Recall # F-443-4.
CODE
a) Use By 07 SEP 04, case code PINE 12645 07 SEP 04 E2;
b) Use By 01 SEP 04 case codes BC 12644 01 SEP 04 E1,
BC 12644 01 SEP 04 E2.
RECALLING FIRM/MANUFACTURER
Kraft, Inc., Northfield, IL, by e-mail, fax, and visit on August 20, 2004. Firm initiated recall is ongoing.
REASON
Premature spoilage due to yeast fermentation.
VOLUME OF PRODUCT IN COMMERCE
18,759 cases.
DISTRIBUTION
Nationwide, Aruba and the Grand Caymen Islands.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Natural Creations Spur Relief, for external use only. Recall #
D-271-4.
CODE
Z30428 and Z28324.
RECALLING FIRM/MANUFACTURER
Apotheca Naturale, Inc., Woodbine, IA, by telephone on August 19, 2004. Firm initiated recall is complete.
REASON
Unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
260/2-fl. Oz. bottles.
DISTRIBUTION
IA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-1983-4.
CODE
Unit number: W0013 03 200069.
RECALLING FIRM/MANUFACTURER
Department of the Air Force, 59th Medical Wing/MTLLB, Lackland AFB, TX, by telephone on March 4, 2003. Firm initiated recall is complete.
REASON
Blood product, with a decreased platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1984-4.
CODE
Unit number: W90796.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by telephone on March 15, 2004. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding Platelets were possibly contaminated with bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # 1987-4.
CODE
Unit number: 11LL10029A.
RECALLING FIRM/MANUFACTURER
American Red Cross, Missouri-Illinois Region, St. Louis, MO, by telephone on July 7, 2003. Firm initiated recall is complete.
REASON
Blood product, corresponding to Platelets Pheresis, Leukocytes Reduced that were possibly contaminated with coagulase-negative, Staphylococcus sp., was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MO.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1999-4.
CODE
Unit number: 2038237.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on February 2, 2004, and by letter, dated February 18, 2004. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with coagulase-negative, Staphylococcus warneri, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Source Plasma. Recall # B-2003-4.
CODE
Unit numbers: BSDLKJA, BSDLPZA, BSDMCPA, BSDMPNA, BSDNHYA, BSDNMTA, BSDNWLA, BSDPDMA, BSDPQKA, BSDPWNA, BSDQKKA, BSDRDRA.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc. St. Paul, MN, by letter, dated November 21, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor who had been permanently deferred due to drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-2012-4.
CODE
Units 16GQ17699 and 16GQ17705.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Columbus, OH, by telephone June 11, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor whose hematocrit was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2018-4.
CODE
Units 027GH18885 and 027LQ16774.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone on March 16, 2004, and by letter dated March 30, 2004. Firm initiated recall is complete.
REASON
Blood products, which had no documentation that irradiation was adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WV.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-2019-4;
b) Fresh Frozen Plasma, Recall # B-2020-4.
CODE
a) and b) Unit 027LK13192.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone on April 1, 2004, and by letter dated April 1, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WV.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-2021-4;
b) Recovered Plasma. Recall # B-2022-4.
CODE
a) and b) Unit 027LK12322.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone on April 4, 2004, or e-mail on April 8, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WV, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-2023-4;
b) Recovered Plasma. Recall # B-2024-4.
CODE
a) and b) Unit 027LC27348.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone or e-mail on April 12, 2004, and by letter dated April 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA and CA.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-2025-4;
b) Recovered Plasma. Recall # B-2026-4.
CODE
a) and b) Unit 027LC26720.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone on April 13, 2004, and by letter or e-mail dated April 14, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WV, and CA.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-2027-4.
CODE
Unit 027LQ11229.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by e-mail on April 14, 2004. 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
CA.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-2028-4;
b) Recovered Plasma. Recall # B-2029-4.
CODE
a) and b) Unit 027LW24603.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA Ohio and California by telephone or e-mail on April 8, 2004, and by letter dated April 9, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH, and CA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-2030-4.
CODE
Unit KR11466.
RECALLING FIRM/MANUFACTURER
ITXM Clinical Services, Pittsburgh, PA, by facsimile on November 12, 2003. Firm initiated recall is complete.
REASON
Blood product, which was positive for the Kell antigen but was labeled negative for the Kell antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Platelets Pheresis Irradiated. Recall # B-2031-4.
CODE
Unit E75912.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, Pennsylvania by telephone and by letter dated March 15, 2004. Firm initiated recall is complete.
REASON
Blood product, which had no documentation that irradiation was adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Source Plasma. Recall # B-1846-4.
CODE
Unit: 77832405
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank Inc. of Wisconsin, Milwaukee, WI, by fax on October 24, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-2010-4.
CODE
Unit numbers: BGXHTB, BGXHJB, BGXGRP, BGXGDV, and BGTRNG.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Knoxville, TN, by facsimile on October 30, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for all infectious diseases, but were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
IL, and Germany.

_______________________________
PRODUCT
Platelets Leukocytes Reduced. Recall # B-2011-4.
CODE
Unit 042GE12940.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH, by telephone and by letter on April 21, 2004. Firm initiated recall is complete.
REASON
Blood product, which was quarantined due to a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-2014-4.
CODE
Units 150217090, 150216933, 150216924, 150217087.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by telephone on July 23, 2003. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for HIV/HCV NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX, and New Mexico.

_______________________________
PRODUCT
Blood Cells Leukocytes Reduced Irradiated. Recall # B-2032-4.
CODE
Units 71L191227, 71L025932, 71L317916, and 71L173406.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on March 26, 2004. Firm initiated recall is complete.
REASON
Blood products, which were labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
FL.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Amigo Insulin Infusion Pump. Model #s 990001, 990002, 990003, 990004, 990005, and 990006. Recall # Z-1335-04.
CODE
All associated codes.
RECALLING FIRM/MANUFACTURER
Nipro Diabetes Systems, Inc, Miramar, FL, by letter and/or telephone on May 7, 2004. Firm initiated recall is complete.
REASON
A FDA inspection of the firm revealed deficiencies in the company’s quality system. Problems exhibited may include motor failure or unintended operation.
VOLUME OF PRODUCT IN COMMERCE
8.
DISTRIBUTION
NY, NJ, FL, IN, UT, CO, and WY.

_______________________________
PRODUCT
a) Standard and Custom Spinal Trays with 5% Lidocaine
Hydrochloride 2 ml ampul. Recall # Z-1439-04;
b) Standard and Custom Spinal Trays with 7.5% Dextrose Injection
USP 2 ml ampul. Recall # Z-1440-04.
CODE
a) Catalog number 333027 Lot number 60544516,
Catalog number 333200 Lot number 60536446,
Catalog number 333210 Lot numbers 60536450 and 60542855,
Catalog number 333230 Lot number 60542857,
Catalog number 333742 Lot numbers 60536470, 60544549, and
60544550, Catalog number 333752 Lot number 60544557,
Catalog number 333852 Lot numbers 60536493 and 60544563,
Catalog number 333861 Lot numbers 60517577 and 60517578,
Catalog number 333872 Lot number 60544582,
Catalog number 560074 Lot number 60537371,
Catalog number 560123 Lot number 60549408,
Catalog number 560130 Lot number 60549409,
Catalog number 560156 Lot number 60547692,
Catalog number 560176 Lot number 60537460,
Catalog number 560214 Lot number 60563428,
Catalog number 560269 Lot number 60540604,
Catalog number 560327 Lot numbers 60537472 and 60549429,
Catalog number 560386 Lot number 60549439,
Catalog number 560397 Lot number 60527954,
Catalog number 560399 Lot number 60540619,
Catalog number 560408 Lot number 60537475,
Catalog number 560436 Lot number 60549863,
Catalog number 560485 Lot number 60540907, and
Catalog number 560505 Lot number 60566553;
b) Catalog number 333027 Lot number 60544516,
Catalog number 333200 Lot number 60536446,
Catalog number 333210 Lot numbers 60536450 and 60542855,
Catalog number 333230 Lot number 60542857,
Catalog number 333742 Lot numbers 60536470, 60544549, and
60544550,
Catalog number 333752 Lot number 60544557,
Catalog number 333852 Lot numbers 60536493 and 60544563,
Catalog number 333861 Lot numbers 60517577 and 60517578,
Catalog number 333872 Lot number 60544582,
Catalog number 560074 Lot number 60537371,
Catalog number 560123 Lot number 60549408,
Catalog number 560130 Lot number 60549409,
Catalog number 560156 Lot number 60547692,
Catalog number 560176 Lot number 60537460,
Catalog number 560214 Lot number 60563428,
Catalog number 560269 Lot number 60540604,
Catalog number 560327 Lot numbers 60537472 and 60549429,
Catalog number 560386 Lot number 60549439,
Catalog number 560397 Lot number 60527954,
Catalog number 560399 Lot number 60540619,
Catalog number 560408 Lot number 60537475,
Catalog number 560436 Lot number 60549863,
Catalog number 560485 Lot number 60540907, and
Catalog number 560505 Lot number 60566553.
RECALLING FIRM/MANUFACTURER
B. Braun Medical, Inc., Allentown, PA, by letter dated July 8, 2004. Firm initiated recall is ongoing.
REASON
Drug ampuls in kits contain particulates.
VOLUME OF PRODUCT IN COMMERCE
2,261 cases.
DISTRIBUTION
FL, NC, NY, OH, and PA.

_______________________________
PRODUCT
Anestar Anesthesia Delivery System. Recall # Z-1441-04.
CODE
Serial#: 4600010001; 4600010003; 4600010004; 4600010007; 4600010008; 4600010009; 4600010010; 4600010012; 4600A20017; 4600A20018; 4600A20019; 4600A20020; 4600A20021; 4600A20023; 4600A20024; 4600A30066; 4600A30067; 4600A30068; 4600A30069; 4600A30070; 4600A30071; 4600A30072; 4600A30073; 4600A30074; 4600A30075; 4600B10002; 4600B20025; 4600B20026; 4600B20027; 4600B20028; 4600B20029; 4600B20030; 4600B20031; 4600B20032; 4600B20033; 4600B20034; 4600B30076; 4600B30077; 4600B30078; 4600B30079; 4600B30080; 4600B30081; 4600B30082; 4600B30083; 4600B30084; 4600B30086; 4600C30087; 4600C30088; 4600C30089; 4600C30091; 4600C30092; 4600C30093; 4600C30094; 4600C30095; 4600C30096; 4600C30097; 4600C30098; 4600C30099; 4600D20035; 4600D20036; 4600D20037; 4600D20038; 4600D20039; 4600D20040; 4600D20041; 4600D20042; 4600D20043; 4600D20044; 4600H20045; 4600H20046; 4600H20047; 4600H20048; 4600H20049; 4600H20050; 4600H20051; 4600H20052; 4600H20053; 4600H20054; 4600I10013; 4600J20055; 4600J20056; 4600J20057; 4600J20058; 4600J20059; 4600J20060; 4600J20061; 4600J20062; 4600J20063; 4600J20064.
RECALLING FIRM/MANUFACTURER
Datascope Corp., Mahwah, NJ, by a Field Correction action initiated in June, 2003 and completed by the service reps in April 2004. Firm initiated recall is complete.
REASON
Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.
VOLUME OF PRODUCT IN COMMERCE
89 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Axiom Sensis Report Workstation. Recall # Z-1446-04.
CODE
Serial Numbers 1002, 1034, 1100-1253, 1300-1504.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by a Customer Safety Advisory on May 17, 2004. Firm initiated recall is ongoing.
REASON
Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.
VOLUME OF PRODUCT IN COMMERCE
234 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge
Knee Tibial Component, precoat, nonmodular, size 2, sterile,
for cemented use only; Cat. No. 5880-02-02. Recall # Z-1447-
04;
b) Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge
Knee Tibial Component, precoat, nonmodular, size 3, sterile,
for cemented use only; Cat No. 5880-03-02. Recall # Z-1448-
04.
CODE
a) Lot 60037871; Exp, June 2008;
b) Lot 60004557; Exp. December 2008.
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated August 3, 2004 and a dear doctor letter dated August 25, 2004. Firm initiated recall is complete.
REASON
The polyethylene tibial bushing was omitted from the taper of the tibial plates.
VOLUME OF PRODUCT IN COMMERCE
33
DISTRIBUTION
Nationwide and Germany.

______________________________
PRODUCT
a) Axiom Artis BA or BC Biplane System, Angiographic x-ray
system. Model number 59 04 649. Recall # Z-1449-04;
b) Axiom Artis BA or BC Biplane System, Angiographic x-ray
system. Model number 59 04 656. Recall # Z-1450-04.
CODE
a) Serial numbers: 14002-14004, 14006-14012, 14014, 14018,
14021, 14025, 14029, 14033, 14041-14042, 14044-14045, 14049,
14051, 14055, 14058, 14060-14065, 14064-14065, 14068, 14071,
14074-14075, 14080-14081, 14084-14088, and 14092;
b) Serial numbers: 28000, and 28002-28118.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on August 12, 2004. Firm initiated recall is ongoing.
REASON
Opacification Function of device may incorrectly merge images.
VOLUME OF PRODUCT IN COMMERCE
71 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
DANA Diabecare II insulin pumps. Recall # Z-1451-04.
CODE
Serial numbers: AEE001FC – AEE039FC, AEE041FC, AEE043FC - AEE048FC, AEE083FC – AEE132FC.
RECALLING FIRM/MANUFACTURER
Dana Diabecare USA LLC, New Orleans, LA, by email, letters and telephone on May 26, 2004. Firm initiated recall is ongoing.
REASON
There is a switch malfunction that may cause the unit not to respond when command key is depressed.
VOLUME OF PRODUCT IN COMMERCE
37 units.
DISTRIBUTION
AZ, WV, PA, FL, WI, MI, TN, and MD.

_______________________________
PRODUCT
a) BV25 Mobile X-Ray System. Recall # Z-1453-04;
b) BV25 Gold Mobile X-Ray System. Recall # Z-1454-04;
c) BV26 Mobile X-Ray System. Recall # Z-1455-04;
d) BV29 Mobile X-Ray System. Recall # Z-1456-04;
e) BV212 Mobile X-Ray System. Recall # Z-1457-04;
CODE
For all devices: Part #s 980762000001, 980762000101, 980762010001, 980762010101, 980762020001, 980762020201, 984910000031, 984910000101, 989600006051, 989600006091, 989600006281, 989600006282, 989600007041, 989600007731 Site #s 59630, 104099, 101968, 101961, 101964, 59628, 59631, 59632, 101967, 101963, X1118, X1178, X1463, X1346, X1190, X1465, X0532, X1455, X1452, X1239, X1060, 300026, 300027, 13695, 10305, 13047, 13587, 13663, 35451, 13552, 15281, 13298, 13687, 14152, 13626, 15189, 13542, 15067, 10407, 13144, 15063, 14164, 13498, 13222, 13233, 13301, 15175, 13150, 82476, 15316, 13272, 5153, 13602, 15074, 14129, 15083, 13630, 82475, 13445, 10018, 15091, 59693, 13964, 13938, 13236, 4013, 6674, 6749, 59454, 6815, 6737, 6630, 6765, 6787, 81887, 6848, 5160, 6492, 4258, 6658, 6830, 6304, 101929, 6618, 6692, 6748, 4115, 6307, 6677, 4065, 4290, 6868, 6729, 4125, 6537, 6724, 6708, 4170, 6561, 76866, 5162, 5159, 4224, 6745, 5055, 6589, 34132, 34149, 35419, 38965, 35170, 34088, 34749, 34061, 35442, 34138, 34302, 34790, 67090, 61430, 34668, 504447, 35164, 35405, 81878, 34107, 34547, 34182, 34093, 41190, 61989, 31004, 34844, 34300, 35399, 34004, 31332, 67947, 35379, 35468, 16734, 17189, 17413, 17182, 16409, 17316, 16726, 16405, 16703, 41343, 41344, 16694, 17405, 16284, 16768, 16285, 16639, 17235, 17314, 17407, 16764, 16623, 17269, 16374, 16178, 17396, 17424, 17244, 16761, 16161, 17343, 16156, 16621, 16691, 16727, 17536, 16170, 17617, 17251, 17390, 16275, 61745, 17397, 17590, 81925, 16172, 61841, 17586, 76354, 16225, 16701, 17450, 17542, 16233, 17287, 17374, 16749, 16573, 16683, 17449, 17126, 16226, 16197, 17352, 16209, 16693, 17242, 17454, 17367, 17243, 17423, 62623, 62471, 61192, 17104, 17322, 17593, 17614, 76088, 17618, 76115, 17564, 16697, 10183, 17543, 87600, 76103, 17551, 37216, 76092, 17554, 16682, 76581, X0637, 17555, 76028, 17615, 76423, 16359, 16370, 40100, 17234, 17517, 17159, 16641, 16752, 16671, 16689, 16341, 16440, 16437, 17255, 16627, 16442, 16679, 86928, 76421, 76366, 76177, 76061, 17478, 17462, 17463, 86927, 76032, 67082, 17479, 17532, 76419, 76418, 17619, 17526, 100718, 17461, 76158, 76447, 76171, 6744, 76096, 76157, 6725, 76422, 76176, 76169, 76175, 76139, 17685, 84925, 16131, 16132, 17180, 16583, 17257, 16582, 17345, 16141, 16771, 13416, 15087, 16000, 13551, 17188, 13540, 16719, 16732, 17548, 17518, 82474, 16663, 17173, 16069, 16717, 16037, 16746, 16058, 16060, 17200, 17342, 16012, 16014, 17332, 16571, 17451, 16072, 59683, 17375, 16059, 16620, 16105, 82939, 17308, 16702, 16022, 17181, 16076, 16099, 59479, 84727, 13888, 13563, 13524, 13434, 13490, 13357, 10347, 13428, 13536, 10370, 13889, 13435, 15204, 13671, 13419, 10304, 13343, 13303, 13647, 15146, 44098, 10082, 13390, 10084, 10297, 82481, 84726, 15263, 15172, 15170, 59690, 13437, 10003, 15276, 13495, 13270, 15171, 10078, 19056, 62545, 61969, 19510, 38706, 62262, 61911, 38260, 61865, 19258, 19010, 62370, 19051, 62005, 62336, 19449, 62267, 68212, 84922, 19090, 19549, 62570, 62263, 61894, 19293, 62510, 62465, 62269, 61825, 62466, 61821, 61858, 14024, 104651, 19147, 62349, 6198, 6200, 6909, 76845, 76946, 6199, 6201, 6809, 6514, 10143, 104034, 13395, 6515, 44846, 6801, 6827, 6746, 6593, 59478, 6529, 6731, 6361, 84797, 6760, 6736, 6666, 25618, 6690, 6518, 6768, 6156, 6595, 10373, 15237, 13535, 15238, 13347, 10311, 13493, 43110, 13375, 15308, 10372, 15174, 10316, 13342, 10326, 13597, 15307, 13393, 10315, 13526, 10433, 15249, 13505, 13352, 13944, 13553, 15169, 10365, 13676, 10248, 13438, 13638, X1123, 505404, 504453, X1396, 81879, X1378, 84926, 81864, 84975, 81868, 81880, X0275, 81865, 84923, 81877, 250049, 84933, 81871, 250121, X1530, 59685, 250833, 81888, 250774, 250047, X0555, X1513, 250818, X1210, 37051, 37662, 37675, 37664, 37816, 37270, 37225, 37686, 37909, 37650, 38001, 37495, 37956, 37331, 37032, 37468, 37829, 37160, 37198, 37137, 37855, 37854, 37243, 37122, 37671, 37947, 37311, 37085, 37180, 37437, 37106, 43254, 37333, 37207, 37711, 37610, 37890, 100720, 37292, 37317, 38178, 37644, 37900, 37945, 37994, 37649, 38098, 59681, 35328, 59629, 34388, 34315, 35175, 34394, 34445, 35145, 41204, 35169, 34457, 35263, 35370, 35352, 41162, 34838, 35225, 31138, 35189, 35382, 35380, 35193, 31258, 100682, 34352, 41161, 41160, 35490, 37867, 62446, 37415, 37418, 37444, 37676, 37934, 37899, 37972, 37518, 37920, 37696, 37984, 37843, 504058, 37985, 37898, 37522, 37718, 37635, 37862, 37858, 37925, 37527, 37545, 83368, 37971, 37685, 38079, 37588, 37973, 37870, 37541, 37825, 37569, 37834, 37586, 37700, 37706, 37697, 37581, 37871, 37614, 37860, 37519, 37597, 37605, 37543, 37819, 37540, 37917, 37974, 37672, 37602, 37609, 37931, 37891, X0323, 35232, 34746, 35160, X0895, 35183, 34811, 35161, X1454, X0525, X0107, 104443, X1451, 38886, X1244, 104428, X1461, 35242, X1462, 34692, 35353, 31044, 35174, 31147, X0896, 104433, 31078, 90025, 35467, 34664, 31075, 31272, 35440, 81855, 35367, 34217, 31033, 80304, 31241, 34682, 35316, 35393, 34831, 35224, 34689, 82685, 41159, 31232, 31184, 31024, 31054, 31185, 31016, 31011, 31260, 35178, 59567, 34752, 31097, 31145, 31233, 35092, 31106, 35262, 31230, 31144, 41365, 31069, 31098, 37993, 34794, 41175, 31090, 34832, 104252, 504111, 504110, 35611, 35610, 41203, 41187, 82472, 41205, X0651, 105468, X1263, 105593, 104405, X0561, X0318, 104222, X0262, 104214, X0259, 104278, 506108, 104305, X0527, X0188, 104290, X1350, 506614, X0266, X0315, X0314, 104262, 104258, 104320, 104226, 37921, 37902, 37361, 37677, 37669, 37367, 37505, 37399, 38150, 35582, 38151, 37349, 37645, 37362, 37388, 37659, 37373, 25030, 25946, 25108, 25610, 47067, 25185, 25963, 25092, 25852, 25169, 25074, 25944, 25880, 38436, 26033, 25960, 59625, 25068, 84832, 25896, 25816, 25942, 25812, 26167, 38432, 25212, 25594, 25810, 25066, 25861, 26078, 26000, 82625, 59688, 25797, 26146, 25654, 25819, 28271, 26115, 25857, 25818, 26096, 25617, 26079, 26112, 25352, 25378, 25382, 25771, 40008, 25622, 25593, 49479, 25957, 25840, 25869, 25703, 28280, 28262, 4130, 25879, 28275, 19150, 25590, 31117, 40005, 67070, 26083, 25339, 26002, 25323, 40232, 25956, 25624, 25542, 505557, 28230, 25844, 25620, 46013, 26034, 25436, 26284, 28244, 61877, 25507, 25677, 25438, 25985, 26132, 26049, 37976, 25437, 14111, 25280, 28273, 25411, 25916, 25283, 25274, 25678, 26087, 25906, 84473, 25982, 25277, 37577, 25180, 25188, 25996, 28152, 40970, 28130, 26054, 28094, 28217, 25659, 26084, 28277, 28104, 26050, 25831, 28022, 25913, 25914, 26104, 26097, 38383, 31123, 25894, 26013, 28054, 504444, 250409, 250415, 250414, 250416, X0273, 250465, 250455, 84918, X0342, X0306, X0319, X0291, X1617, 250226, 504308, X0263, X0640, 250266, 504759, 505166, X1376, 250251, 250304, X1605, X0249, X0299, 13003, 250108, 19331, 62550, 62327, 19300, 82473, 61850, 19307, 61861, 38272, 62427, 62249, 62411, 62295, 19334, 19526, 19559, 62000, 61999, 62652, 19064, 58721, 65278, 59433, 83656, 59168, 81898, 59330, 43059, 81890, 58922, 59128, 81897, 58762, 84915, 58131, 59169, 58258, 58949, 59247, 58866, 81853, 58651, 81893, 58263, 84914, 84999, 59199, 59355, 81859, 81891, 58230, 59336, 58242, 58682, 84920, 59430, 59215, 81886, 84908, 81894, 58841, 58720, 84911, 59266, 59257, 59452, 58695, 58343, 59061, 58677, 59356, 58925, 58663, 59282, 58324, 59172, 59203, 59485, 59142, 101557, 68087, 67579, 68218, 67673, 67060, 67995, 67981, 67994, 68209, 68148, 67180, 38890, 67674, 68175, 68164, 67064, 67323, 85631, 59696, 82484, 4187, 38570, 10480, 59191, 13299, 58852, 82480, 38664, 82477, 59367, 59477, 104100, 59680, 58450, 58874, 17433, 83383, 59671, 82504, 58927, 84906, 10479, 58947, 104101, 104093, 59105, 84720, 10437, 13273, 38663, 504114, 59694, 58393, 84974, 58830, 59627, 83657, 59626, 59695, 59486, 59624, 104094, 59684, 82482, 59410, 83621, 82478, 6205, 59686, 59232, 10438, 59482, 59125, 82819, 38569, 58451, 82479, 84921, 83620, 83622, 58395, 59678, 59691, 59322, 82702, 59445, 59062, 61811, 59415, 61705, 61750, 61831, 61566, 61826, 61523, 62326, 61746, 61919, 62343, 62534, 61521, 61998, 85456, 82525, 61511, 62541, 58053, 59397, 59290, 59186, 59106, 59372, 58801, 59178, 59420, 101549, 58899, 59354, 58032, 58012, 58884, 67541, 68190, 67365, 67298, 68127, 68222, 67401, 67357, 67885, 67494, 67545, 68182, 68082, 67417, 67568, 67047, 38945, 67495, 68004, 61937, 62321, 62441, 62351, 61479, 38869, 61752, 61469, 61928, 61827, 62568, 61472, 61774, 62367, 62511, 62194, 61161, 61236, 61176, 61308, 61936, 62599, 62338, 62462, 61971, 62509, 62437, 62258, 62542, 61285, 61797, 62426, 61729, 62396, 61000, 67984, 61003, 62372, 62334, 62277, 62412, 61007, 84960, 61399, 62247, 62246, 62271, 61401, 68206, 62410, 61959, 67996, 38851, 61744, 61930, 59682, 62538, 61806, 67451, 81858, 67989, 67210, 67914, 81883, 67902, 68253, 38891, 67304, 67912, 67909, 68046, 81884, 67540, 67770, 67913, 68084, 67907, 504107, 67814, 67160, 67248, 68225, 67351, 67677, 67291, 67266, 67382, 67169, 68205, 68161, 67928, 68221, 67349, 34153, 67496, 67265, 67930, 67929, 67775, 68119, 38911, 68122, 68172, 67526, 67563, 67927, 67780, 67369, 68158, 67267, 67254, 67316, 67562, 38910, 41387, 67676, 67449, 38864, 67834, 68174, 65218, 37006, 73518, 73857, 73485, 73313, 37008, 37007, 64342, 37009, 64686, 73782, 73833, 73416, 73312, 59660, 37628, 64335, 73873, 64294, 65236, 73868, 65263, 64201, 65210, 73514, 73913, 64152, 64032, 64057, 65254, 64172, 74038, 65167, 64053, 74042, 73955, 64178, 73953, 64107, 82596, 73354, 65245, 81873, 73956, 65224, 73954, 6325, 64088, 64036, 64168, 73827, 64195, 73565, 38669, 59399, 73843, 81874, 74085, 64125, 64073, 64240, 38687, 73994, 73975, 64167, 73887, 74050, 64099, 65234, 73993, 64598, 64673, 58220, 64647, 65183, 73288, 64434, 73401, 73961, 64443, 64355, 64423, 74052, 65289, 82485, 64545, 74065, 73379, 64460, 65196, 73272, 73914, 64430, 38688, 73537, 73991, 64554, 73527, 73940, 64389, 64450, 73413, 73948, 64419, 64511, 64472, 64499, 65173, 65248, 65197, 73848, 64275, 64478, 500005, 64399, 64414, 73866, 73853, 100480, 73451, 64356, 64437, 64404, 59687, 64433, 64410, 64446, 73439, 65247, 64364, 64420, 73881, 6196, 6190, 6207, 6598, 6114, 6871, 6805, 6800, 6412, 6115, 6371, 6335, 6197, 6195, 6188, 6179, 6804, 6791, 84795, 6534, 6670, 6540, 6014, 6186, 84796, 6099, 6747, 6769, 6779, 6341, 59481, 6189, 76821, 6187, X0563, X0562, X0558, X0559, X0535, X0538, X0258, X0564, X0526, X0311, X0316, X0300, 10067, X0301, X0906, X0092, 6487, X0547, X0549, X0519, X0548, X0551, X0313, X0560, X0552, 64514, 44731, 49166, 50170, 44847, 49627, 50093, 43442, 49596, 44856, 44561, 44849, 84917, 74082, 44704, 43025, 49165, 44758, 49296, 44756, 49692, 50144, 44984, 49229, 49718, 49075, 49182, 50092, 49282, 49260, 49185, 49183, 49172, 50049, 49257, 49731, 50041, 49154, 49706, 50106, 49179, 44961, 50133, 44853, 49292, 49714, 83032, 58379, 50123, 49353, 50198, 50005, 49031, 50124, 49580, 49728, 49387, 49499, 50071, 49683, 44762, 50082, 44775, 49673, 84919, 50084, 50000, 50172, 59689, 49607, 49459, 49048, 50001, 50059, 49373, 81876, 50008, 49726, 50040, 49400, 81889, 49376, 83835, 49685, 49118, 44234, 43758, 43291, 43236, 44072, 43094, 44265, 44855, 44637, 43999, 43295, 44702, 43274, 44317, 44881, 43006, 43739, 44227, 44016, 44874, 44638, 43005, 44015, 44207, 44789, 43348, 81856, 44617, 43822, 44700, 43262, 44025, 43744, 44165, 43168, 44102, 43355, 44289, 300566, 43368, 43196, 43353, 43824, 44243, 43370, 44087, 44616, 43823, 44241, 44110, 81854, 43995, 43165, 44240, 44294, 44222, 43959, 43371, 43086, 44309, 43215, 43286, 43950, 43345, 44643, 44171, 44009, 43720, 44050, 44720, 44666, 43475, 47130, 44778, 44201, 44764, 50138, 44776, 49341, 40026, 46295, 46240, 82501, 46410, 46271, 46325, 46060, 46059, 46487, 38334, 46006, 47093, 40114, 46090, 46097, 47153, 46957, 40124, 46104, 46111, 46272, 46036, 46888, 47111, 46072, 46327, 40910, 83959, 47179, 46101, 46100, 47064, 46958, 46575, 40331, 47119, 40424, 59677, 46371, 46945, 40744, 47183, 47184, 38277, 47011, 40121, 40135, 46495, 53072, 40772, 40775, 40444, 40165, 46546, 46622, 40120, 47024, 46416, 46988, 40319, 40070, 47142, 41039, 40076, 83902, 61837, 46478, 40146, 53073, 40293, 47030, 40715, 46992, 47129, 47096, 46966, 40036, 83006, 47010, 40274, 40391, 47143, 47001, 40485, 81895, 40820, 84927, 47088, 40640, 46415, 40214, 40242, 47170, 40199, 46965, 40268, 40186, 40362, 46414, 40227, 40395, 505644, 47003, 46938, 40239, 40251, 46361, 40266, 40700, 40827, 46662, 40255, 47104, 46544, 40363, 40228, 40183, 50391, 46625, 40359, 46402, 100019, 46914, 46912, 40335, 40776, 46429, 40384, 46850, 46937, 40336, 40193, 46953, 46522, 46365, 40351, 40155, 47038, 46523, 46989, 40294, 46939, 40247, 46858, 40747, 46843, 40347, 46554, 46627, 47063, 47059, 40349, 47004, 40817, 46962, 47081, 47268, 44875, 40808, 46623, 40012, 46976, 40322, 40080, 44678, 40047, 40288, 40943, 40049, 100315, 46514, 40337, 40942, 40380, 59622, 40855, 40299, 81928, 47049, 47181, 46253, 81927, 46431, 44725, 46934, 47074, 6991, 46181, 46210, 46285, 46549, 46127, 46128, 46200, 46307, 16765, 81929, 46157, 41006, 40018, 40042, 46214, 46291, 46842, 46223, 47008, 47118, 46923, 46290, 47079, 46230, 47120, 46221, 44724, 43895, 505766, 44880, 44613, 44600, 44088, 43617, 44601, 44765, 43382, 44622, 44583, 43615, 43531, 44209, 101672, 44198, 44210, 44052, 6151, 101671, 43908, 43042, 4284, 44811, 43668, 44741, 43558, 59623, 43556, 17245, 13681, 10068, 13581, 16152, 15295, 13451, 15075, 6237, 6823, 13468, 13541, 81881, 6999, 15288, 15210, 13477, 4229, 13386, 15078, 15290, 13588, 10312, 37472, 13694, 13668, 13746, 76899, 26067, 13422, 52359, 59704, 67879.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letter dated July 19, 2004. Firm initiated recall is ongoing.
REASON
Potential for c-arm to move due to loose screws.
VOLUME OF PRODUCT IN COMMERCE
1,900 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Jackson Original Stainless Steel Tracheostomy Tubes, item
number 1034300 size 00, item number 1034310 size 0, item
number 1034311 size 1, item number 1034312 size 2, item
number 1034313 size 3, item number 1034314 size 4, item
number 1034315 size 5, item number 1034316 size 6, item
number 1034317 size 7, item number 1034318 size 8, item
number 1034319 size 9, item number 1034320 size 10.
Recall # Z-1458-04;
b) Jackson Original Short Stainless Steel Tracheostomy Tubes,
item number 1034600 size 00, item number 1034610 size 0, item
number 1034611 size 1, item number 1034612 size 2, item
number 1034613 size 3, item number 1034614 size 4, item
number 1034615 size 5, item number 1034616 size 6, item
number 1034617 size 7, item number 1034618 size 8, item
number 1034619 size 9, item number 1034620 size 10.
Recall # Z-1459-04;
c) Jackson Improved Stainless Steel Tracheostomy Tubes, item
number 1034900 size 00, item number 1034910 size 0, item
number 1034911 size 1, item number 1034912 size 2, item
number 1034913 size 3, item number 1034914 size 4, item
number 1034915 size 5, item number 1034916 size 6, item
number 1034917 size 7, item number 1034918 size 8, item
number 1034919 size 9, item number 1034920 size 10.
Recall # Z-1460-04;
d) Jackson Improved Short Stainless Steel Tracheostomy
Tubes, item number 8100465 size 1, item number 8100373
size 3, item number 1034924 size 4, item number 1034925
size 5, item number 1034926 size 6, item number 1034927
size 7, 1034928 size 8, item number 8100468 size 9,
item number 8100234 size 10. Recall # Z-1461-04;
e) Jackson Improved Short Stainless Steel Tracheostomy
Tubes, item number 1034930 size 00, item number 1034940
size 0, item number 1034941 size 1, item number 1034942
size 2, item number 1034943 size 3, item number 1034944
size 4, item number 1034945 size 5, item number 1034946
size 6, item number 1034947 size 7, item number 1034948
size 8, item number 1034949 size 9, item number 1034950
size 10. Recall # Z-1462-04;
f) Jackson Improved Short Stainless Steel with Adapter
Tracheostomy Tubes, item number 8100402 size 3,
item number 8100040 size 4, item number 8100041 size 5,
item number 8100229 size 6, item number 8100322 size 7,
item number 8100374 size 8, item number 8100282 size 9,
and item number 8100709 size 10. Recall # Z-1463-04;
g) Jackson Improved Extra Long Stainless Steel Tracheostomy
Tubes, item number 1034964 size 4, item number 1034965
size 5, item number 1034966 size 6, item number 1034967
size 7, item number 1034968 size 8, item number 1034969
size 9, and item number 1034970 size 10. Recall # Z-1464-04;
h) Air Lon Nylon, Tracheostomy Tubes, item number 1050150 size
3, item number 1050152 size 4, item number 1050154 size 5,
item number 1050156 size 6, item number 1050158 size 7, and
item number 1050160 size 8. Recall # Z-1465-04;
i) Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter)
Nylon, Tracheostomy Tubes, item number 1050180 size 3, item
number 1050182 size 4, item number 1050184 size 5, item
number 1050186 size 6, item number 1050188 size 7, and item
number 1050190 size 8. Recall # Z-1466-04;
j) Laryngectomy Tubes, Martin Stainless Steel, item number
1036128 size 8 and item number 1036130 size10. Recall # Z-
1467-04;
k) Jackson Original Stainless Steel Laryngectomy Tubes, item
number 1037214 size 4, item number 1037215 size 5, item
number 1037216 size 6, item number 1037217 size 7, item
number 1037218 size 8, item number 1037219 size 9, and item
number 1037220 size 10. Recall # Z-1468-04;
l) Laryngectomy Tubes, Jackson Improved Stainless Steel, item
number1037414 size 4, item number 1037415 size 5, item number
1037416 size 6, item number 1037417 size 7, item number
1037418 size 8, item number 1037419 size 9, and item number
1037420 size 10. Recall # Z-1469-04;
m) Air Lon Nylon Laryngectomy Tubes, item number1050170 size 8
and item number 1050172 size 10. Recall # Z-1470-04;
n) Air Lon Inhalation Set (Inner Cannula with 15 mm Adapter)
Nylon Laryngectomy Tubes, item number 1050200 size 8 and item
number 1050202 size 10. Recall # Z-1471-04.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Premier Dental Products Co., Plymouth Meeting, PA, by letters dated August 5, 2004 and August 11, 2004. Firm initiated recall is ongoing.
REASON
Foreign objects (polishing stones) in the tubes.
VOLUME OF PRODUCT IN COMMERCE
22,324 tubes.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Zoll M Series Automated Defibrillator (AED). Recall # Z-1472-04.
CODE
Software Versions below 34.00.
RECALLING FIRM/MANUFACTURER
Zoll Medical Corp., Chelmsford, MA, by letter on August 2, 2004. Firm initiated recall is ongoing.
REASON
Visual Screen display and audible prompt may not advise to “Press Shock”.
VOLUME OF PRODUCT IN COMMERCE
5,649 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
XSYSTEMS Dilution Buffer, list number 9519-02, for In Vitro diagnostic use, Bovine gamma globulin in Phosphate buffer, with Siduyn Azude as a oreservatuvem 950 mL bottle, 4 bottles per carton. Recall # Z-1474-04.
CODE
List number 9519-02, all lots.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letters dated September 1, 2004. Firm initiated recall is ongoing.
REASON
The XSYSTEMS Dilution Buffer when used with TDx/TDxFLx Benzodiazepines assay can cause shifts in control values and patient results.
VOLUME OF PRODUCT IN COMMERCE
22,442 cartons.
DISTRIBUTION
Nationwide and Internationally.

______________________________
PRODUCT
a) Siregraph CF X-Ray System. Fluoroscopic image intensified.
Model number 4466033. Recall # Z-1475-04;
b) Siregraph CF X-Ray System. Fluoroscopic image intensified.
Model number 4466041. Recall # Z-1476-04.
CODE
a) Serial numbers: 1506, 1528, 1529, 1539, 1544, 1568, 1572,
1633, 1821, 1841, 1864, 1877, 2020, 2023, and 2126.
b) Serial number: 3131.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated June 7, 2004. Firm initiated recall is ongoing.
REASON
Unintended X-ray tube movement when table is tilted more than 90 degrees.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
FL, IL, MI, NH, NJ, PA, and TX.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
ProSpecT Campylobacter Microplate Assay. Catalog #2476096. Recall # Z-1372-04.
CODE
Lot #910718.
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa KS, by letter on July 15, 2002. Firm initiated recall is complete.
REASON
A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
VOLUME OF PRODUCT IN COMMERCE
382.
DISTRIBUTION
Russelsheim, Germany.

____________________________
PRODUCT
a) Manual Biopsy Devices containing AIM system: Chiba Needle, 6
inch/15 cm, 22 gauge, Catalog #40-102, Material #M001401021
(10 per box).Recall # Z-1442-04;
b) Manual Biopsy Devices containing AIM system: Chiba Needle,
8 inch/20 cm, 22 gauge, Cat. #40-103, Material #M001401031
(10 per box). Recall # Z-1443-04;
c) Manual Biopsy Devices containing AIM system: Crown Biopsy
Needle: 6 inch/15 cm, 22 gauge, Cat. #40-404, Material
#M001404041 (10 per box). Recall # Z-1444-04;
d) Manual Biopsy Devices containing AIM system: Co-Axial Lung
Biopsy Needle, 6 inch/15 cm, 22 gauge, Cat. #40-600, Material
#M001406001 (5 per box).Recall # Z-1445-04.
CODE
a) 6503654, 6513396, 6544512;
b) 6503081, 6507526;
c) 6528003, 6577339;
d) 6528009.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Natick, MA, by letters dated August 9, 2004. Firm initiated recall is ongoing.
REASON
Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.
VOLUME OF PRODUCT IN COMMERCE
186 cartons.
DISTRIBUTION
Nationwide and Italy.

_______________________________
PRODUCT
ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests). Recall # Z-1452-04.
CODE
List 6C09-20, lots 11002M300, 11003M300, 16051M200, 18288M300;
List 6C09-25, lots 11002M301, 16051M201, 18288M301.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter on August 19, 2004. Firm initiated recall is ongoing.
REASON
Changes in the ARCHITECT B12 Reagent lots may adversely affect the shape of the calibration curve, over time. These changes may produce controls out of range low and similar decreases in patient sample values prior to current expiration of the reagents.
VOLUME OF PRODUCT IN COMMERCE
5,754 kits.
DISTRIBUTION
Internationally.

END OF ENFORCEMENT REPORT FOR September 22, 2004

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