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U.S. Department of Health and Human Services

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Enforcement Report for April 19, 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.

April 19 2006
06-16

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

______________________________
PRODUCT
Frozen Cheeseburgers - beef patties with American Cheese on a bun, a closed meat sandwich. The cheeseburgers were packaged under the following labels: a) Jimmy Dean Mini 24 Cheeseburgers Beef Patties with Real American Cheese on a Bun; 12 Twin Packs, Net Wt. 38.4 oz, Keep Frozen, Microwaveable; 10 retail packages per case; Dist. By Sara Lee Foods, UPC 77900-28305 b) State Fair Cheeseburgers Beef Patties with Cheese on a Bun; 6 Sandwiches, Net Wt 9.6 oz., Microwaveable, Keep Frozen, Fully Cooked, Ready to Heat & Eat; 20 packages per case; State Fair Foods, UPC 71068-44606, Recall # F-141-6
CODE
Jimmy Dean label: codes 05294, 05314, 05321;
State Farm label: code 05326
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sara Lee Foods, Downers Grove, IL, by press release, telephone and fax on December 13, 2005.
Manufacturer: Sara Lee Foods, Florence, AL manufactured the Jimmy Dean Cheeseburgers. The Sate Fair Cheeseburgers and the Rudy's Farm Chicken Biscuits were manufactured by Peacock Engineering, Itasca, IL, firm initiated recall is complete.
REASON
The cheese burgers were assembled with sliced American processed cheese that may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
1,560 cases of cheeseburgers, 798 cases of chicken biscuits
DISTRIBUTION
TX, TN, NC, IN, GA, PR and Bermuda

______________________________
PRODUCT
a) Carpathian brand Caviar Japanese Orange Tobiko in 4 oz plastic tubs,
2 oz and 8 oz containers, Recall # F-142-6;
b) Carpathian brand Caviar Japanese Black Tobiko in 4 oz plastic tubs,
2 oz and 8 oz containers, Recall # F-143-6;
c) Carpathian brand Caviar Japanese Wasabi Tobiko in 4 oz plastic tubs,
2 oz and 8 oz containers, Recall # F-144-6
CODE
All codes
RECALLING FIRM/MANUFACTURER
Flying Salmon Inc, San Francisco, CA, by telephone and letter on February 7, 2006, and by press release on February 14, 2006, firm initiated recall is ongoing.
REASON
a) The product contains undeclared ingredients including Soybean, FD&C Yellow #6,
FD&C Red #40, Wheat, and Monosodium Glutamate;
b) The product contains undeclared ingredients including Soybean, FD&C Yellow #5,
FD&C Red #40, Wheat, and Monosodium Glutamate;
c) The product contains undeclared ingredients including Soybean, FD&C Yellow #5,
Wheat, and Monosodium Glutamate
VOLUME OF PRODUCT IN COMMERCE
Orange: 3 - 2oz jars, 50 - 4oz plastic tubs; Wasabi: 24 - 4oz plastic tubs; Black: 30 - 4oz plastic tubs
DISTRIBUTION
CA

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
a) SODIUM THIOSULFATE INJECTION, USP, 10%, 100 mg/mL
(1g/10 mL), 10 mL SINGLE DOSE VIAL and 5 x 10 mL SINGLE
DOSE VIALS, Rx Only, NDC 0517-1019-05, Recall # D-212-6;
b) SODIUM THIOSULFATE INJECTION, USP, 25%, 250 mg/mL
(12.5 g/50 mL), 50 mL SINGLE DOSE VIAL, Rx Only, NDC 0517-5019-01,
Recall # D-213-6
CODE
a) Lot 5309 (exp. May 2008);
b) Lot 4769 (exp. December 2007) and 5404 (exp. June 2008)
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley, NY, by letters, dated March 1, 2006, firm initiated recall is ongoing.
REASON
Failed specification for pH.
VOLUME OF PRODUCT IN COMMERCE
63,564 vials
DISTRIBUTION
Nationwide, and Hong Kong

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Member’s Mark brand Aspirin 81 mg, Enteric Safety Coated, Adult Low Strength, 500 tablet bottles, NDC 68196-535-90, Recall # D-226-6
CODE
Lots 5ME0540 and 5ME0956
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI, by letter on March 24, 2006, firm initiated recall is ongoing.
REASON
Mislabeled; drug identification logo “L535" may not have been completely embossed onto the tablet.
VOLUME OF PRODUCT IN COMMERCE
14,652 bottles
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Member’s Mark brand Maximum Strength Allergy Sinus Daytime (acetaminophen 500 mg, chlorpheniramine maleate 2 mg and phenylephrine HC1 5 mg) Caplets, packaged in 100 + 100 =200 Caplet bottles, NDC 68196-223-78, Recall # D-227-6
CODE
Lots 5HE0910, 5HE0911, 5HE0912, 5HE0913, 5HE0914, 5HE0915, 5JE0747, 5JE0748, 5KE0261, 5KE0940, 5JE0942, 5KE0944, 5KE0945, 5KE0946, 5LE0569, 5LE0769, 5LE0770, 5KE0085, 5ME0179, 5ME0248, 5ME0689, 6AE0396, 6AE0397, 6AE0422 and 6AE0791
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI, by letter dated March 24, 2006, firm initiated recall is ongoing.
REASON
The tamper evident seal on the carton states 'sealed in blister units for your protection', but the product is actually packaged in bottles.
VOLUME OF PRODUCT IN COMMERCE
364,644 cartons
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Focalin XR (dexmethylphenidate HCL), 5 mg, CII, 100 capsules, NDC 0078-0430-05, Rx only, Recall # D-228-6
CODE
Lot F0003 , Exp. JUL 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals, Corp., Suffern, NY, by letters, dated March 9, 2006.
Manufacturer: Elan Holdings, Inc., Gainesville, GA, firm initiated recall is ongoing.
REASON
Superpotent
VOLUME OF PRODUCT IN COMMERCE
14,001 -- 100 count bottles
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
Human Tissue for Transplantation: Corneas, Recall # B-0676-6
CODE
ID numbers: 05-2203, 05-2204
RECALLING FIRM/MANUFACTURER
Georgia Eye Bank, Atlanta, GA, by telephone and follow-up letter on or about February 8, 2006. Firm initiated recall is complete.
REASON
Human Corneas, inadequately tested for infectious diseases in that the blood sample used for testing may have been hemodiluted, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
GA

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0805-6;
b) Cryoprecipitated AHF, Recall # B-0806-6
CODE
a) and b) Unit number: 027X21038
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on October 13, 2005 and follow-up letter on October 14, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WV and MD

______________________________
PRODUCT
Red Blood Cells, Recall # B-0877-6
CODE
Unit number: 49W47679
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by telephone, letter, fax and ARC Logic Computer beginning March 7, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX and CA

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0879-6;
b) Red Blood Cells Irradiated, Recall # B-0880-6;
c) Red Blood Cells, B-0881-6;
d) Red Blood Cells (Apheresis), Recall # B-0882-6;
e) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0883-6;
f) Platelets Pheresis Leukocytes Reduced, Recall # B-0884-6
CODE
a) Units: S57275, S57263, S53709, S53715, S55472, S55483, S55491, S55496,
S55499, S55945, S55953, S55967, S57240, S57262, S57266, KC87131, KC87134;
b) Unit: S52760;
c) Units: S57279, S55949, S55973;
d) Units: S57241, S57283, S55966, S57259;
e) Units: S57245, S57274, S57283, S57243, S55946, S55950;
f) Units: S55966 (split product), S57241
RECALLING FIRM/MANUFACTURER
HCSC-Blood Center, Bethlehem, PA, by telephone on July 21, 2005 and follow-up Recall Notification on August 26, 2005. Firm initiated recall is complete
REASON
Blood products, tested for CMV with unacceptable QC results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
PA

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0920-6
CODE
Unit 12W03915 (split unit)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by telephone on May 11 and 20, 2005 and by letter dated May 20, 2005. 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
NC
_____________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0948-6
CODE
Unit 12KP91034
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by telephone on June 14, 2005 and by letter dated June 21, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who did not meet acceptable hemoglobin specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0949-6
CODE
Unit 03KE25187
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Atlanta, GA, by letter dated September 16, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0951-6;
b) Platelets Leukocytes Reduced, Recall # B-0952-6
CODE
a) and b) Unit 33GS66196
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone and letter on December 15, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CT

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Recovered Plasma, Recall # B-0878-6
CODE
Unit number: 49W47679
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by telephone, letter, fax and ARC Logic Computer beginning March 7, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX and CA

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0918-6;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0919-6
CODE
a) Unit 7380492;
b) Unit 0157063
RECALLING FIRM/MANUFACTURER
Marquette General Hospital, Marquette, MI, by telephone and by letter dated November 9, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had a history of arthritis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI and FL

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0926-6
CODE
Unit: 36GR11627
RECALLING FIRM/MANUFACTURER
The American National Red Cross, South Carolina Region, Columbia, SC, by telephone on May 19, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor at risk for leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

______________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0942-6;
b) Plasma Cryoprecipitate Reduced, Recall # B-0943-6;
CODE
a) and b) Unit 12FG10650
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Charlotte, NC, by telephone on March 12, 2005 and by letter dated March 20, 2005. Firm initiated recall is complete.
REASON
Blood products, which were not collected in accordance with standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA and NC

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

This is an extension of Class I recall # Z-0524/0526-06, reported in the March 1, 2006, Enforcement Report:

______________________________
PRODUCT
a) Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7" x 10.7"
Code: 0010206, Recall # Z-0524-06;
b) Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8" x 13.7"
(25.4cm x 33cm) Code: 0010207, Recall # Z-0525-06;
c) Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 7.7" x 9.7"
(19.6cm x 24.6cm) Code: 0010208, Recall # Z-0526-06;
d) Bard® Composix® Kugel Large Oval, 5.4" x 7" for hernia repairs
Product Code: 0010202, Recall # Z-0760-06;
e) Bard® Composix® Kugel Large Circle, 4.5" for hernia repairs
Product Code: 0010204, Recall # Z-0761-06;
f) Bard® Composix® Kugel Oval, 6.3 x 12.3"' for hernia repairs
Product Code: 0010209, Recall # Z-0762-06
CODE
a), b), and c) Lot Codes: 41XMXXXX -- M = 2002, 41XNXXXX -- N = 2003,
43XMXXXX -- M = 2002, 43XNXXXX -- N = 2003,
43XOXXXX -- O = 2004, 43XPXXXX -- P = 2005. If the lot number
does not contain either M, N, O or P as the 4th character the lot is
not affected by this recall;
d), and e) Lot Numbers: 41*L****, 41*M****, 41*N**** 43*L****, 43*M****, 43*N****;
f) All Lot Numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Cranston, RI, by letters on December 22, 2005, December 27, 2005, January 5, 2006 and March 24, 2006.
Manufacturer: Bard, Las Piedras, PR, firm initiated recall is ongoing.
REASON
Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Z-0760/0762-06 extension of recall Z-0524/0526-06)
VOLUME OF PRODUCT IN COMMERCE
31,761 units + 50,506 in recall extension
DISTRIBUTION
Nationwide, Australia, Canada, and Japan

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Recall # Z-0715-06
CODE
Lot number: 06011817
RECALLING FIRM/MANUFACTURER
Rubicor Medical, Inc., Redwood City, CA, by visit on February 17, 2006 and by letter, dated March 13, 2006, firm initiated recall is complete.
REASON
Devices’ sterility may be compromised due to lack of adequate sterilization.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous), Recall # Z-0717-06
CODE
Lot codes: 3124050609-01, 3124050609-02, 3124050609-03, 3124050803-01, 3124050803-02, 3124050803-03, 3124050803-04, 3124050803-05, 3124050623-01, 5313050323-01, 5313050620-01, 5306050624-01, 5306050623-01, 5306050323-01, 4568050622-01, 4568050415-01, 3195050217-06, 3195050511-01, 3195050426-12, 3195050511-02, 3195050511-03, 3195050511-05, 3195050511-07, 3195050511-08, 3195050511-10, 3195050520-07, 3195050412-05, 3195050418-02, 3195050418-03, 3195050418-06, 3195050418-07, 3195050418-09, 3195050418-13, 3195050418-14, 3195050418-15, 3195050426-01, 3195050426-02, 3195050426-03, 3195050426-04, 3195050426-05, 3195050426-11, 3195050426-13, 3195050426-14, 3195050426-15, 3195050511-09, 3195050511-11, 3195050511-12, 3195050511-13, 3195050511-14, 3195050511-15, 3195050520-01, 3195050520-02, 3195050520-03, 3195050520-04, 3195050520-05, 3195050527-02, 3195050527-03, 3195050527-04, 3195050527-05, 3195050527-06, 3195050527-07, 3195050527-08, 3195050131-08, 3195050120-02, 3195050120-07, 3195050120-08, 3195050120-09, 3195050114-03, 3195050527-12, 3195050527-13, 3195050527-14, 3195050527-15, 3195050609-01, 3195050609-02, 3195050609-04, 3195050722-07, 3195050609-07, 3155050722-04, 3155050722-05, 3195050811-03, 3195050426-07, 3195050609-09, 3195050811-04
RECALLING FIRM/MANUFACTURER
Recalling Firm: Respironics, Inc., Murrysville, PA, by letter, telephone and e-mail on January 3, 2006.
Manufacturer: Caradyne Ltd., Galway, Ireland, firm initiated recall is ongoing.
REASON
Vapotherm humidification cartridges were found to contain microbial (Ralstonia spp.) cultures. This device uses cartridges from the same supplier.
VOLUME OF PRODUCT IN COMMERCE
83 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) METRx II Tube, 14mm x 3cm stainless steel tubular retractor,
Part No. 9569660, Recall # Z-0719-06;
b) METRx II Tube, 14mm x 4cm stainless steel tubular retractor,
Part No. 9569661, Recall # Z-0720-06;
c) METRx II Tube, 14mm x 5cm stainless steel tubular retractor,
Part No. 9569662, Recall # Z-0721-06;
d) METRx II Tube, 14mm x 6cm stainless steel tubular retractor,
Part No. 9569663, Recall # Z-0722-06;
e) METRx II Tube, 14mm x 7cm stainless steel tubular retractor,
Part No. 9569664, Recall # Z-0723-06;
f) METRx II Tube, 14mm x 8cm stainless steel tubular retractor,
Part No. 9569665, Recall # Z-0724-06;
g) METRx II Tube, 14mm x 9cm stainless steel tubular retractor,
Part No. 9569666, Recall # Z-0725-06;
h) METRx II Tube, 16mm x 3cm stainless steel tubular retractor,
Part No. 9569670, Recall # Z-0726-06;
i) METRx II Tube, 16mm x 4cm stainless steel tubular retractor,
Part No. 9569671, Recall # Z-0727-06;
j) METRx II Tube, 16mm x 5cm stainless steel tubular retractor,
Part No. 9569672, Recall # Z-0728-06;
k) METRx II Tube, 16mm x 6cm stainless steel tubular retractor,
Part No. 9569673, Recall # Z-0729-06;
l) METRx II Tube, 16mm x 7cm stainless steel tubular retractor,
Part No. 9569674, Recall # Z-0730-06;
m) METRx II Tube, 16mm x 8cm stainless steel tubular retractor,
Part No. 9569675, Recall # Z-0731-06;
n) METRx II Tube, 16mm x 9cm stainless steel tubular retractor,
Part No. 9569676, Recall # Z-0732-06;
o) METRx II Tube, 18mm x 3cm stainless steel tubular retractor,
Part No. 9569680, Recall # Z-0733-06;
p) METRx II Tube, 18mm x 4cm stainless steel tubular retractor,
Part No. 9569681, Recall # Z-0734-06;
q) METRx II Tube, 18mm x 5cm stainless steel tubular retractor,
Part No. 9569682, Recall # Z-0735-06;
r) METRx II Tube, 18mm x 6cm stainless steel tubular retractor,
Part No. 9569683, Recall # Z-0736-06;
s) METRx II Tube, 18mm x 7cm stainless steel tubular retractor,
Part No. 9569684, Recall # Z-0737-06;
t) METRx II Tube, 18mm x 8cm stainless steel tubular retractor,
Part No. 9569685, Recall # Z-0738-06;
u) METRx II Tube, 18mm x 9cm stainless steel tubular retractor,
Part No. 9569686, Recall # Z-0739-06;
v) METRx II Tube, 20mm x 3cm stainless steel tubular retractor,
Part No. 9569720, Recall # Z-0740-06;
w) METRx II Tube, 20mm x 4cm stainless steel tubular retractor,
Part No. 9569721, Recall # Z-0741-06;
x) METRx II Tube, 20mm x 5cm stainless steel tubular retractor,
Part No. 9569722, Recall # Z-0742-06;
y) METRx II Tube, 20mm x 6cm stainless steel tubular retractor,
Part No. 9569723, Recall # Z-0743-06;
z) METRx II Tube, 20mm x 7cm stainless steel tubular retractor,
Part No. 9569724, Recall # Z-0744-06;
aa) METRx II Tube, 20mm x 8cm stainless steel tubular retractor,
Part No. 9569725, Recall # Z-0745-06;
bb) METRx II Tube, 20mm x 9cm stainless steel tubular retractor,
Part No. 9569726, Recall # Z-0746-06;
cc) METRx II Tube, 22mm x 3cm stainless steel tubular retractor,
Part No. 9569730, Recall # Z-0747-06;
dd) METRx II Tube, 22mm x 4cm stainless steel tubular retractor,
Part No. 9569731, Recall # Z-0748-06;
ee) METRx II Tube, 22mm x 5cm stainless steel tubular retractor,
Part No. 9569732, Recall # Z-0749-06;
ff) METRx II Tube, 22mm x 6cm stainless steel tubular retractor,
Part No. 9569733, Recall # Z-0750-06;
gg) METRx II Tube, 22mm x 7cm stainless steel tubular retractor,
Part No. 9569734, Recall # Z-0751-06;
hh) METRx II Tube, 22mm x 8cm stainless steel tubular retractor,
Part No. 9569735, Recall # Z-0752-06;
ii) METRx II Tube, 22mm x 9cm stainless steel tubular retractor,
Part No. 9569736, Recall # Z-0753-06
CODE
a) Lot No. FA05K003;
b) Lot No. FA05K004;
c) Lot No. FA05K005;
d) Lot No. FA05K006;
e) Lot No. FA05K007;
f) Lot No. FA05K008;
g) Lot No. FA05K009;
h) Lot No. FA05K010;
i) Lot No. FA05K011;
j) Lot No. FA05K012;
k) Lot No. FA05K013;
l) Lot No. FA05K014;
m) Lot No. FA05K015;
n) Lot No. FA05K016;
o) Lot No. FA05K017;
p) Lot No. FA05K018;
q) Lot No. FA05K019;
r) Lot No. FA05K020;
s) Lot No. FA05K021;
t) Lot No. FA05K022;
u) Lot No. FA05K023;
v) Lot No. DC05L012;
w) Lot No. DC05L013;
x) Lot No. DC05L014;
y) Lot No. DC05L015;
z) Lot No. DC05L016;
aa) Lot No. DC05L017;
bb) Lot No. DC05L018;
cc) Lot No. DC05L005;
dd) Lot No. DC05L006;
ee) Lot No. DC05L007;
ff) Lot No. DC05L008;
gg) Lot No. DC05L009;
hh) Lot No. DC05L010;
ii) Lot No. DC05L011
RECALLING FIRM/MANUFACTURER
Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, by letter dated January 25, 2006, firm initiated recall is ongoing.
REASON
Due to a manufacturing error, after autoclaving, the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off.
VOLUME OF PRODUCT IN COMMERCE
61 devices
DISTRIBUTION
IL, IN, MI, CA, Japan, and Netherlands

______________________________
PRODUCT
SenoScan Full Field Digital Mammography System, Product number 94001G-3, 105200G, Recall # Z-0757-06
CODE
Software versions earlier than 5.2.2
RECALLING FIRM/MANUFACTURER
Fischer Imaging Corporation, Denver, CO, by letter on March 27, 2006, firm initiated recall is ongoing.
REASON
Software upgrade to preclude lost images during mammography procedure.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS)
manufactured with feedthrus from a specific supplier are being removed
from the market. Model number CI-1400-01, Recall # Z-0758-06;
b) The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS)
manufactured with feedthrus from a specific supplier are being removed
from the market. Model number CI-1400-02H, Recall # Z-0759-06
CODE
a) Serial numbers: 310383, 306002, 224839, 310129, 308039, 310558, 225444,
225541, 301020, 309066, 310003, 310135, 310284, 310141, 310142, 310490,
310466, 310475, 309002, 303070, 306090, 310712, 310023, 222652, 223588,
300220, 301490, 302089, 303086, 307009, 310495, 225722, 304072, 304086,
304093, 310007, 310116, 310286, 310332, 302219, 310138, 310136, 310444,
310557, 310718, 310336, 307093, 222772, 310439, 301394, 300216, 304094,
306045, 310131, 310170, 310391, 310354, 310461, 309058, 310115, 310165,
310392, 310485, 305062, 310211, 308057, 310161, 310440, 301381, 225289,
301094, 225603, 306078, 310421, 220798, 222078, 225301, 307059, 309004,
310010, 310125, 310373, 310418, 310643, 310130, 306075, 302023, 301969,
301979, 310012, 223481, 310424, 222826, 310698, 303085, 308022, 310347,
310031, 310034, 301809, 301818, 310148, 310231, 310566, 310788, 307063,
304045, 301835, 310013, 310508, 302109, 302135, 306011, 220223, 303059,
310433, 225560, 225725, 301347, 310313, 310376, 310459, 310639, 310792,
302036, 310284, 309034, 309009, 309013, 310127, 310128, 302114, 305010,
306015, 308031, 222653, 224598, 301517, 222982, 225438, 310242, 310295,
310330, 310393, 310510, 310672, 310638, 310493, 301885, 225384, 225396,
225400, 225463, 225565, 310486, 302285;
b) Serial numbers: 350550, 350974, 350386, 350613, 350654, 350687, 350714,
350754, 350859, 350964, 350998, 351006, 351031, 351035, 351063, 351129,
351132, 351139, 350568, 350121, 350486, 350514, 350581, 350655, 350896,
350955, 350958, 350967, 350452, 350816, 350949, 350959, 350963, 351021,
351140, 350489, 350492, 350505, 350555, 350789, 350910, 250914, 350957,
351036, 350565, 351020, 350251, 350283, 350482, 350509, 350519, 350524,
350525, 350527, 350531, 350532, 350583, 350676, 350689, 351046, 350535,
350220, 350224, 350239, 350246, 350250, 350254, 350256, 350260, 350294,
351069
RECALLING FIRM/MANUFACTURER
Advanced Bionics Corp., Sylmar, CA, by letters on March 8, 2006, firm initiated recall is ongoing.
REASON
Certain HiRes 90K cochlear implants could fail as a result of elevated moisture levels. The unimplanted HiRes 90K implants listed are being removed from the market. Patients are to be followed for signs of device failure: intermittent function, complete loss of sound, sudden discomfort, pain, noise, or popping.
VOLUME OF PRODUCT IN COMMERCE
613 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse. Nonpyrogenic. The SPYDER is designed to create an anastomosis in a rapid, automated fashion. The device creates an interrupted anastomosis without the need for aortic clamping. A specially designed aortic cutting device (ACD) (sold separately) is utilized to create the site for the anastomosis, Recall # Z-0763-06
CODE
All units with Use Before Dates earlier than June, 2007
RECALLING FIRM/MANUFACTURER
Medtronic Cardiac Surgery Technologies, Minneapolis, MN, by letter on September 1, 2005, firm initiated recall is ongoing.
REASON
Customers stated that the U-Clip deployment collar was either difficult to rotate or “locks up" during usage, which prevents the deployment of the U-Clips.
VOLUME OF PRODUCT IN COMMERCE
3383 units
DISTRIBUTION
Nationwide, Japan, Belgium, Netherlands, Singapore, and Thailand

______________________________
PRODUCT
Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide Sterilized, Recall # Z-0764-06
CODE
Lot number: 5710119-175140, 5710790-180727, 5710941-181455, 5710942-181456, 5711046-181820, 5711047-18121, 5711227-183395, 5711397-185711, 5711448-186781, 5711724-190560, 5711777-191665, 5711930-194095, 5712202-197704, 5712203-197705, 5712254-198709, 5712255-198710, 5712256-198711, 5712965-220245, 5713055-221862, 5713056-221864, 5713059-221867, 5713060-221868, 5713061-221869, 5713261-225636, 5713419-227238, 5713420-227239, 5713657-230645, 5713658-230646, 5713789-235178, 5714079-239059, 5714507-246886, 5714566-247028, 5714665-252591, and 5714901-255263. Six pouches of unknown lot number hand carried to the University of Chicago as well as 12 pouches to the University of Missouri.
RECALLING FIRM/MANUFACTURER
Synovis Surgical Innovations A division of Synovis Life Technologies, Inc., St. Paul, MN, by telephone and letters beginning on November 1, 2005, firm initiated recall is ongoing.
REASON
The Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable.
VOLUME OF PRODUCT IN COMMERCE
4,950 pouches
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
GE Healthcare Navigation Pin Transmitter Catalog Number 1004070, Medical Systems Insta Trak Pin Transmitter, Recall # Z-0709-06
CODE
Serial numbers: 82-2771-N, 822920-N, 82-2921-N, 82-3012-N, 82-3188-N, 82-3189-N, 82-3289-N, 89-2453-N, 89-2509-N, 89-2524-N, 89-2529-N, 89-2742-N, 89-2743-N, 89-3121-N, 89-3122-N, 89-3123-N, 8S-2094-N, 8S-2150-N, 8S2151-N, 8S-2177-N, 8S-2178-N, 8S-2179-N, 8S-2223-N, 8S-2224-N, 8S-2225-N, 8S-2226-N, 8S-2244-N, 8S-2261-N, 8S-2262-N, 8S-2292-N, 8S-2336-N, 8S-2337-N, 8S-2338-N, 8S-2339-N, 8S-2340-N, 8S-2341-N, 8S-2376-N, 8S-2380-N, 8S-2386-N, 8S-2390-N, 8S-2394-N, 8S-2443-N, 8S-2444-N, 8S-2445-N, 8S-2515-N, 8S-2516-N, 8S-2524-N, 8S-2549-N, 8S-2589-N, 8S-2590-N, 8S-2591-N, IT25147P, IT25169P, IT35153P, IT35184P, IT35191P, IT35197P, IT35198P, IT35207P, IT35208P, IT35209P, IT35211P, IT35214P, IT35216P, IT35221P, IT35223P, IT35225P, IT35226P, IT35228P, IT35232P, IT35234P, IT35240P, IT35242P, IT35244P, IT35245P, IT35250P, IT35255P, IT35260P, IT35262P, IT35263P, IT35267P, IT35269P, IT35272P, IT35275P, IT35280P, IT35285P, IT35287P, IT35291P, IT35292P, IT35293P, IT35294P, IT35295P, IT35296P, IT35299P, IT35301P, IT35302P, IT35304P, IT35305P, IT35312P, IT35315P, IT35316P, IT35317P, IT35323P, IT35324P, IT35327P, IT35328P, IT35330P, IT35336P, IT35339P, IT35342P, IT35344P, IT35348P, IT35361P, IT 35370P, IT35375P, IT35379P, IT35381P, IT35383P
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on February 6, 2006, firm initiated recall is ongoing.
REASON
Small retaining pin may detach and fall into the surgical field during stereotactic surgery.
VOLUME OF PRODUCT IN COMMERCE
185 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
AxiEM EM Knee Kit, and associated workstation, Catalog number: 9732140, Recall # Z-0718-06
CODE
Lot numbers: 2005100642 and 2005100645
RECALLING FIRM/MANUFACTURER
Medtronic Navigation, Inc., Louisville, CO, by letter on February 1, 2006, firm initiated recall is complete.
REASON
Knee Navigation Disposable Kits were programmed with an incorrect identification number on the tracker ROM chip which would not permit navigation during surgery.
VOLUME OF PRODUCT IN COMMERCE
84 kits
DISTRIBUTION
Nationwide, Australia, Austria, Israel, Singapore, Switzerland, and UK

______________________________
PRODUCT
a) Cronex™ 10T, 14 x 17, Medical Screen Film, X-ray Film, 100 Sheet Box,
Product code: LF5Ha, Recall # Z-0754-06;
b) Curix™ Ultra UV-L Plus, Medical Screen Film, X-ray Film, 14 x 17,
100 Sheet Box, Product code: EKQEG, Recall # Z-0755-06;
c) Radiomat™ SG, 11 x 14, Medical Screen Film, X-ray Film, 100 Sheet Box,
and 14 x 17, 100 Sheet Box, Product code: EK8JR and Product Code: EK8DG,
Recall # Z-0754-06;
CODE
a) Lot number: 79340139;
b) Lot number: 79340029;
c) Lot number: 79360104
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by telephone on February 16, 2006.
Manufacturer: AGFA, Corp., Goose Creek, SC, firm initiated recall is ongoing.
REASON
A localized fog pattern appears on the film.
VOLUME OF PRODUCT IN COMMERCE
712 stacks
DISTRIBUTION
Nationwide and Canada

 

END OF ENFORCEMENT REPORT FOR APRIL 19, 2006

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