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U.S. Department of Health and Human Services

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Enforcement Report for January 31, 2007

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.

 

January 31, 2007
07-05

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS I

_____________________________
PRODUCT
Whole Treat Organic Vanilla Ice Cream Bars Dipped in Chocolate, 3/3oz. individually wrapped bars/container; UPC #99482-41350, Recall # F-110-7
CODE
BB02AUG07 41-40 06214 with a timestamp greater than 21:25.
RECALLING FIRM/MANUFACTURER
Recalling Firm Name and Address: Whole Foods Market, Austin, TX, by e-mail on beginning on November 6, 2006.
Manufacturer: Oregon Ice Cream, LLC, Eugene, OR. Firm initiated recall is ongoing.
REASON
Product contains undeclared almonds. Whole Treat Organic Vanilla Ice Cream Bars dipped in Chocolate and Almonds were packaged in containers labeled for the same product but without Almonds.
VOLUME OF PRODUCT IN COMMERCE
42 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS II

______________________________
PRODUCT
a) ATKINS Advantage Morning Start Apple Crisp Breakfast Bars,
5 - 1.3 OZ. (37g) BARS, NET WT. 6.5 OZ. (180 g), UPC Code 637480309127.
PRODUCT OF CANADA. Each bar is individually wrapped in a white and
yellow colored wrapper, 5 bars per box, Recall # F-096-7;
b) ATKINS Advantage Morning Start Chocolate Chip Crisp Breakfast Bars,
5 - 1.3 OZ. (37g) BARS, NET WT. 6.5 OZ. (185 g), UPC Code 637480309028.
PRODUCT OF CANADA. Each bar is individually wrapped in a white and
brown colored wrapper, 5 bars per box, Recall # F-097-7;
c) ATKINS Advantage Morning Start Peanut Butter Crisp Breakfast Bars,
5 - 1.3 OZ. (38g) BARS, NET WT. 6.7 OZ. (190 g), UPC Code 637480358439.
PRODUCT OF CANADA. Each bar is individually wrapped in a white and light
brown colored wrapper, 5 bars per box, Recall # F-098-7
CODE
a) Best By/Lot Code Sep 14, 2007;
b) Best By/Lot Code Sep. 05, 2007;
c) Best By/Lot Code Aug. 31, 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Atkins Nutritionals, Inc., Melville, NY, by telephone and email on September 29, 2006 and by letters on October 6, and October 12, 2006.
Manufacturer: Multibar Foods, Inc., Montreal Quebec, Canada. Firm initiated recall is ongoing.
REASON
The product may contain plastic pieces. This was discovered when a firm employee noticed a large protrusion in a finished bar traversing down the manufacturing line.
VOLUME OF PRODUCT IN COMMERCE
28,080 bars
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS -- CLASS III

_____________________________
PRODUCT
Krispy Kreme, Honey Bun, Net Wt. 3oz (85G). The product is sold loose and in boxes out of the firm's retail stores. Recall # F-095-7
CODE
Code Dates: 014 090506, 014 090706, 014 090806, 014 091206, 014 091306, 014 091406, 014 091506,014 091906, 014 092006, 014 092106, and 014 092206
RECALLING FIRM/MANUFACTURER
Recalling Firm: Krispy Kreme Doughnut Distribution Center, Winston Salem, NC, by telephone on September 9, 2006.
Manufacturer: Krispy Kreme Donut Company Inc, Concord, NC. Firm initiated recall is complete.
REASON
Incorrect Nutrition Facts labeling of sugar content; The label reads 4g and should have read 11g.
VOLUME OF PRODUCT IN COMMERCE
130,752 units
DISTRIBUTION
Nationwide

_____________________________
PRODUCT
a) ROHA FD&C Yellow No. 5, Recall # F-099-7;
b) ROHA FD&C Red No. 3, Recall # F-100-7;
c) ROHA FD&C Red No. 40, Recall # F-101-7;
d) ROHA FD&C Blue No. 1, Recall # F-102-7;
e) ROHA FD&C Blue No. 2, Recall # F-103-7;
f) ROHA FD&C Red No. 40 Aluminum Lake, Recall # F-104-7;
g) ROHA FD&C Blue No. 1 Aluminum Lake, Recall # F-105-7;
h) ROHA FD&C Blue No. 2 Aluminum Lake, Recall # F-106-7;
i) ROHA FD&C Yellow No. 6 Aluminum Lake, Recall # F-107-7;
j) ROHA FD&C Yellow No. 5 Aluminum Lake, Recall # F-108-7;
k) ROHA FD&C Yellow No. 6, Recall # F-109-7
CODE
a) AN2514, AM8480, AM9264, AM9266, AN1641, AN1943, AM6147,
AN0512, AN0513, AN0514, AM9510, AM9542, AN0515, AN0549,
AN1199, AN2125, AN2127, AN2129, AN2133, AN2155, AN2128,
AN2130, AM7912, AM9670, AM9672, AM9673, AM9674, AM9675,
AM9676, AM9677, AN2648, AM6356, AN1644, AN2131, AN2132,
AN1642, AN1647, AN1648, AN1650, AN1645, AN1651, AN1944,
AM6896, AN1734, AN1735, AN1736, AN1737;
b) AM4135, AN5810, AM5642, AM4163, AM9401, AM5641;
c) AM3097, AM3098, AM8205, AM3099, AM3100, AM4727, AM7919,
AM7928, AM9835, AM9864, AM9865, AN1690, AN1779, AN1966,
AN2062, AN2063, AN2065, AN2138, AN1688, AN1689, AN1692,
AM9851, AM9859, AM9860, AM9861, AN1777, AM8810, AM9094,
AM9308, AM6837, AM9666, AM9667, AN1558, AN1240, AN1241,
AN1242, AN1281, AN1968, AN1969, AM9694, AN1243, AN2104, AN2562,
AN2563, AN1280, AN2565, AN2568, AN2068, AN2069, AN1967, AN2001,
AM2904, AM5013, AM6840, AM9302, AM9303, AM9304, AM9307, AN1740,
AN1814, AN0281;
d) AN0228, AM4054, AM9281, AM7483, AM7492, AM7497, AM7622,
AM4000, AM9310, AM4074, AN1754;
e) AM6870, AM6937, AM9296, AM9297, AN2435;
f) AM7530, AM8472, AN1697, AN2079, AN2080, AM1766, AM6958,
AM7168, AN1189, AN1190, AN1191, AM8516, AM8519, AM8520, AM8521;
g) AN1336;
h) AM1145, AM2851, AM2854, AM2858;
i) AM5061, AN0186, AM6725, AM6904, AN0289, AN2622, AN0187,
AN0238, AL9740, AM6913, AM6914, AM7127, AM7128, AN1429,
AM6093, AN1741, AN2623;
j) AM9838, AM9897, AN2655, AN6954, AN1186, AN1187, AN1188,
AM8467, AN0185, AN2547, AN2841;
k) AM9620, AM9698, AN1955, AM2754, AM9278, AN1473, AN1472,
AN1753, AM9518, AM9519, AM9852, AN1657, AN2292, AN2293,
AN2294, AN2295, AN0225, AN0226, AN0227, AM7099, AN0600,
AN1961, AN4141, AM4212, AM7095, AN1960, AN1963, AN1989,
AM8090, AN1958, AN0093, AN0095, AN1956, AN1988, AM9857,
AN0094, AN0096, AN0260, AN1962, AM2612, AM7496, AN1738,
AN1739, AN2613, AN1496
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roha U.S.A., L.L.C., Saint Louis, MO, by telephone on September 25, 2006.
Manufacturer: Roha Dyechem Pvt, LTD., Dhatav, India. Firm initiated recall is ongoing.
REASON
Colors may be non-certified
VOLUME OF PRODUCT IN COMMERCE
246,994 lbs.
DISTRIBUTION
Nationwide and Canada

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

_____________________________
PRODUCT
Methotrexate Injection, USP, (Contains Preservative) 50 mg/2 mL (25 mg/mL), Sterile, Rx drug for I.V. use only; 2 mL single dose vial; NDC 63323-123-02, Recall # D-431-2007
CODE
Lot numbers 200653 and 200656, expiration date 6/2007 for both lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abraxis Pharmaceutical Products, Rosemont, IL,
Manufacturer: Abraxis Pharmaceutical Products, Melrose Park, IL, by letters dated January 8, 2007. Firm initiated recall is ongoing.
REASON
Exceeds specification for pH
VOLUME OF PRODUCT IN COMMERCE
28,482 vials
DISTRIBUTION
Nationwide and Puerto Rico

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

__________________________
PRODUCT
Human Tissue for Transplantation, Recall # B-0471-7:
a) Alloquent LORDOTIC Lumbar Spacer of varying sizes;
b) Alloquent Cervical Spacer 8 mm;
c) Achilles Tendon, Frozen;
d) Cancellous Cubes of varying sizes;
e) Crushed Cancellous, 60 cc;
f) Fascia Lata;
g) Whole Frozen Femur Shaft;
h) Fibula Ring;
i) Fibula Shaft Segment;
j) Frozen Gracilis;
k) Frozen Patella Tendon, Hemi;
l) Patella Wedge;
m) Frozen Semitendinosus
CODE
a) 050404183012 050404183013 050404183014 050404183015 050405183001
050405183002 050405183003 050405183004 050405183006 050405183007
050405183008 050405183009 050404183001 050404183002 050404183003
050404183004 050404183005 050404183006 050404183007 050404183008
050404183009 050404183010 050404183011 050405183010 050405183011
050405183012 050405183013 050405183014 050405183015 050405183016
050405183017 050405183018 050405183019 050405183020 050405183021;
b) 050498184007;
c) 0843701401, 0866301401;
d) 0843721105 0843721107 0843721108 0843721109 0843721110 0843721111
0843721112 0843721113 0843721114 0843721115 0843721116 0843721117
0843721118 0843721119 0843721120 0846821101 0846821102 0846821103
0846821104 0846821105 0846821106 0846821107 0846821108 0849021101
0849021102 0849021103 0849021104 0849021105 0849021106 0849021107
0850021101 0850021102 0850021103 0850021104 0850021105 0850021106
0843721106;
e) 0843711221 0843711222 0846811209 0849011208 0850011207;
f) 0843711903 0843711904 0846811915 0849011915;
g) 0863705302;
h) 0849014010 0849014011 0849014012 0849014013 0850014008;
i) 0846811512 0846811513 0866311502 0866311503;
j) 0843706502 0846806501;
k) 0843704501 0843704502 0843704503 0843704504 0849004501 0863604501
0863604502 0863604503 0866304501 0866304502;
l) 0846814114;
m) 0843706601
RECALLING FIRM/MANUFACTURER
Recalling Firm: TissueNet Custom Applications, LLC, Orlando, FL, by certified letters dated July 10, August 9, and August 25, 2006
Manufacturer: U.S. Tissue and Cell, Cincinnati, OH, and U.S. Tissue and Cell, Salt Lake City, UT. Firm initiated recall is on going.
REASON
Human tissue, recovered from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
108 Allografts
DISTRIBUTION
Nationwide, Canada, Turkey and Greece

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

__________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0389-7;
b) Platelets, Recall # B-0390-7
CODE
a) and b) Unit 0223000
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on April 6, 2005. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from a whole blood unit that was collected in a manner that may have compromised the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0559-07
CODE
Units: 5735707, 5735708, 5735709, 5735788, 5735790, 5735791
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone or facsimile on November 1, 2005, November 2, 2005, or November 8, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
OK and TX

_____________________________
PRODUCT
Source Plasma, Recall # B-0596-7
CODE
Units: ST375163, ST374833, ST374171, ST373854, ST373139, ST372861
RECALLING FIRM/MANUFACTURER
Biomat USA Inc., San Antonio, TX, by fax on March 4, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had previously been permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA

_____________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-0597-7
CODE
Unit: 71X208547
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on October 4, 2005. Firm initiated recall is complete.
REASON
Blood product, with a platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

_____________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-0598-7
CODE
Unit: 71X32333X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Montgomery, AL, by fax on September 12, 2005. Firm initiated recall is complete.
REASON
Blood product, with a platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

__________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0602-7
CODE
Unit: 2234822
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by fax on April 17, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

_____________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0603-7
CODE
Unit: 2235096
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by fax on March 23, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

_____________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0604-7
CODE
Unit: 2615717
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by telephone on October 6, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with corresponding red cell product that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

_____________________________
PRODUCT
Recovered Plasma, Recall # B-0605-7
CODE
Unit: 8652521
RECALLING FIRM/MANUFACTURER
Poudre Valley Health Care, Inc., Blood Bank, Fort Collins, CO, by letter on October 11, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a history of jaundice, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

__________________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced unit numbers, Recall # B-0612-7;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0613-7
CODE
Unit: 5620177 (parts 1 and 2);
Unit: 5620177
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile and telephone on April 8, 2006. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with coagulase negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OK

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0615-07
CODE
Unit: 8606859
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on September 3, 2006. Firm initiated recall is complete.
REASON
Platelets, which was possibly contaminated with Streptococcus viridans and coagulase negative Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0656-7
CODE
Unit: 6038787
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by telephone on September 11, 2006 and by letter dated October 10, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of the medication Avodart, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
DE

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0659-7
CODE
Unit: 5643869
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on June 20, 2006. Firm initiated recall is complete.
REASON
Platelets, which were incorrectly labeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

__________________________________
PRODUCT
Red Blood Cells, Recall # B-0660-7
CODE
Unit: T13160
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rocky River Valley Blood Center, Rockford, IL, by letter dated October 10, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of Hodgkin’s disease, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_____________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0662-7
CODE
Unit 2248466
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by telephone and by letter dated August 8, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications for release, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
DE

_____________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0663-7
CODE
Unit: 2250539
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by telephone and by letter dated August 8, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications for release, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

_____________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0664-7;
b) Platelets Leukocytes Reduced, Recall # B-0665-7
CODE
a) and b) Unit 032KY21735
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Madison, WI, by letter dated June 17, 2003. Firm initiated recall is complete.
REASON
Blood products, which were 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
IL

_____________________________
PRODUCT
Red Blood Cells, Leukocyte Reduced, Recall # B-0666-7
CODE
Unit: 5353960 (split 1&2)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on April 12, 2006. 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
OK

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0667-7
CODE
Units: 4865455, 4706067
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on March 27, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0671-7
CODE
Units: 040FF59312, 040FF59574, 040FF59844
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of American Region, Peoria, IL, by telephone on August 18, 2006 and by facsimile on September 13, 2006. 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
3 units
DISTRIBUTION
IL

_____________________________
PRODUCT
Red Blood Cells, Recall # B-0672-7
CODE
Unit: 9043341
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on June 29, 2006. 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
CO

_____________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0673-07
CODE
Unit: L98324
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax and e-mail on August 24, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of melanoma, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL and NY

_____________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0675-7
CODE
Unit: Y66605
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax on March 30, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of melanoma, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

__________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0676-7;
b) Platelets, Recall # B-0677-7
CODE
a) and b) Unit: Y06435
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on September 29, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

_____________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0678-7
CODE
Unit: L33362
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on September 26, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

_____________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0694-7
CODE
Units: 033GC03620 (2 units), 033GQ01677, 033GX00487
RECALLING FIRM/MANUFACTURER
American National Red Cross, Connecticut Region, Farmington, CT, by telephone on August 23, 2006 and by letter dated August 25, 2006. Firm initiated recall is complete.
REASON
Blood products, with incomplete quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CT

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0695-7
CODE
Unit: W001305200297
RECALLING FIRM/MANUFACTURER
Department of the Air Force, 59th Medical Wing/MTLLB, Lackland AFB, TX, by telephone on July 17, 2005. Firm initiated recall is complete.
REASON
Platelets, which was possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0696-7
CODE
Unit: 11992-1306
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, El Paso, TX, by telephone on October 7, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0697-7
CODE
Unit: 11993-3040
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, El Paso, TX, by telephone on December 11, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0698-7
CODE
Units: 5484530 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on October 10, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0699-7;
b) Recovered Plasma, Recall # B-0700-7
CODE
a) and b) Unit: 4122999
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 23, 2006 or by electronic notification on June 1, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of intravenous drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX and Switzerland

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

__________________________________
PRODUCT
a) Whole Blood, Recall # B-0377-7;
b) Red Blood Cells, Recall # B-0378-7
CODE
a) Units 22LL07976, 22LL07977, 22LL07978, 22LL07979, 22LL07980, 22LL07981,
22LL07982, 22LL07983, 22LL07986, 22LL07988, 22LL07989, 22LL07990,
and 22LL07991;
b) Unit 22LL07984
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Philadelphia, PA, by facsimile on May 19, 2006 and by letter dated May 23, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
PA and NY

_____________________________
PRODUCT
Red Blood Cells, Recall # B-0528-7
CODE
Unit: 3484012
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on October 9, 2006. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0557-7
CODE
Unit: 5612828 (Part 3)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by telephone and facsimile on May 24, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with coagulase negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM

_____________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0599-7
CODE
Unit: 2151664
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by telephone on April 7, 2006 and letter dated April 14, 2006. Firm initiated recall is complete.
REASON
Blood product, out of controlled storage for an undocumented length of time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

__________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0600-7
CODE
Unit: 71X190933
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc, Montgomery, AL, by fax on May 10, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

_____________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Irradiated, Recall # B-0601-7
CODE
Unit: 71W621715
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc, Montgomery, AL, by fax on April 5, 2005. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0609-7
CODE
Unit: 5412327 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile and telephone on May 30, 2005. Firm initiated recall is complete.
REASON
Blood products, possible contaminated with coagulase negative Staphylococcus, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY and OK

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0616-07
CODE
Unit: 3731497 (split A & B)
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on September 15, 2006. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus sp., were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL

__________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0657-07
CODE
Unit: 5734534
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on December 13, 2005 and March 31, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

__________________________________
PRODUCT
Recovered Plasma, Recall # B-0661-7
CODE
Unit: T13160
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rocky River Valley Blood Center, Rockford, IL, by facsimile on October 10, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of Hodgkin’s disease, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

_____________________________
PRODUCT
Recovered Plasma, Recall # B-0668-7
CODE
Units: 4865455, 4706067
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on March 29, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0669-7
CODE
Units: 5499656 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on October 28, 2005. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Staphylococcus capitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY and OK

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0670-7
CODE
Unit: 5444887 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on September 26, 2005. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK

_____________________________
PRODUCT
Recovered Plasma, Recall # B-0674-07
CODE
Unit: L98324
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax and e-mail on August 24, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of melanoma, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL and NY

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

__________________________________
PRODUCT
a) Cyberonics VNS Therapy System, Model 250-'HAND HELD'
programming software v6.1, v6.1.7, v7.0 and v7.1.3,
Recall # Z-0341-2007;
b) Handhelds-Cyberonics VNS Therapy System, Model 2500-'Handhelds'
preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3,
Recall # Z-0342-2007
CODE
a) For Software v6.1: 10-005-9400 and 10-006-0900; For Software v6.1.7:
10-0007-2400 and 10-0007-2500; For Software v7.0: 10-0007-4100
and 10-0007-2500; For Software v7.1.3: 10-0007-8400 and 10-0007-8500;
b) For Handheld v6.0: 99-0000-3000; For Handheld v6.1: 10-0006-4300;
For Handheld v6.1.7: 10-0007-2700, 10-0007-3600, 10-0007-2609
and 77-0000-7000; For Handheld v7.0: 10-0007-4300;
For Handheld v7.1.3: 10-0007-8600.
RECALLING FIRM/MANUFACTURER
Cyberonics, Inc., Houston, TX, by safety alert on November 14, 2006. Firm initiated recall is onging.
REASON
During programming, pulse generator may be inadvertently set to 8.0 mA output, regardless of the mA range selected by the clinician
VOLUME OF PRODUCT IN COMMERCE
3,538 Software; 7,404 Handheld PCs
DISTRIBUTION
Nationwide and Internationally

_____________________________
PRODUCT
Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machin, Article number: 0704629, Recall # Z-0350-2007
CODE
Serial numbers: 101006, 101007, 101008, 101009, 101010, 101011, 101013, 101015, 101016, 101018, 101019, 101020, 101022, 101023, 101024.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet, Inc., Bridgewater, NJ, by visit on December 11, 2006.
Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.
REASON
The HCU 30 system potentially will not be have the power capacity to run the compressor when the heaters are on during operation. This may lead to a situation where the user may not be able to cool the patient and/or cardioplegia sufficiently.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CA, NC, FL, WY, NY and WV

_____________________________
PRODUCT
Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Recall # Z-0361-2007
CODE
Lot number: 29892
RECALLING FIRM/MANUFACTURER
Diagnostic Chemicals, Ltd., Charlottetown Prince Edward Island, Canada, by letter dated December 5, 2006. Firm initiated recall is ongoing
REASON
Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to different end users, DCL cannot be certain which instruments the end users employ in their laboratories.
VOLUME OF PRODUCT IN COMMERCE
55 kits
DISTRIBUTION
PA

_____________________________
PRODUCT
Suros ATEC Breast Biopsy System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter aperture) for use with the ATEC Breast Biopsy and Excision System, disposable, sterile, Part no. 0912-20, Recall # Z-0362-2007
CODE
Lot: 611018
RECALLING FIRM/MANUFACTURER
Suros Surgical Systems, Inc., Indianapolis, IN, by telephone beginning on December 15, 2006 and follow-up letter dated December 19, 2006. Firm initiated recall is ongoing.
REASON
The handpiece package may have an incorrect part number on the inner package. Error could result in over-penetration of the biopsy needle.
VOLUME OF PRODUCT IN COMMERCE
1,249 handpieces
DISTRIBUTION
Nationwide

__________________________________
PRODUCT
Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees, Recall # Z-0363-2007
CODE
Material number 3C85, serial numbers: 200547006, 200547007, 200547008, 200547009, 200547034, 200547035, 200547036, 200547037, 200547038, 200547039, 200548022, 200548023, 200548037, 200548038, 200548039, 200548040, 200548041, 200548042, 200604015, 200604016, 200604017, 200604021, 200604022, 200604024, 200604064, 200605002, 200613003. Material number 3C95, serial numbers: 200531057, 200531058, 200531059, 200531060, 200547003, 200547004, 200547005, 200547024, 200547049, 200547050, 200547051, 200547052, 200547053, 200547054, 200547055, 200547056, 200547057, 200548007, 200548008, 200548009, 200548010, 200548011, 200548012, 200548013, 200548014, 200548015, 200548016, 200548017, 200548018, 200548019, 200548020, 200548034, 200548035, 200548036, 200548044, 200548045, 200548046, 200548047, 200548048, 200548049, 200548051, 200548052, 200548053, 200548054, 200548055, 200548056, 200548058, 200548059, 200548060, 200548061, 200548062, 200548063, 200548064, 200548065, 200548067, 200548068, 200604001, 200604002, 200604003, 200604004, 200604005, 200604006, 200604007, 200604008, 200604009, 200604010, 200604012, 200604013, 200604014, 200604026, 200604027, 200604028, 200604029, 200604030, 200604032, 200604033, 200604034, 200604035, 200604036, 200604038, 200604039, 200604040, 200604041, 200604042, 200604043, 200604044, 200604045, 200604053, 200604054, 200604055, 200604056, 200604057, 200604058, 200604059, 200604062, 200604063, 200605003, 200605004, 200605005, 200605006, 200605008, 200605009, 200605010, 200605018, 200605019, 200605020, 200605021, 200605022, 200605023, 200605054, 200605055, 200605057, 200605058, 200605059, 200605060, 200605061, 200612015, 200612016, 200612017, 200612018, 200612019, 200612020, 200612021, 200612024, 200612029, 200612045, 200612047, 200612050, 200612051, 200612052, 200612053, 200612054, 200612056, 200613034, 200613035, 200613038, 200613039, 200613041, 200613042, 200613043, 200613044, 200613045, 200613054, 200613055, 200613056, 200613057, 200613061, 200613062, 200613063.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bock, Otto, Orthopedic Ind., Inc., Minneapolis MN, by letter dated August 11, 2006.
Manufacturer: Otto Bock Austria, Wien, Austria. Firm initiated recall is ongoing.
REASON
A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A limited number of Compacts have a defective solder connection between the contact wires and battery terminals. If exposed to strong vibrations these Compact knee joints have an increased probability of malfunction and a resultant risk to the Compact wearer.
VOLUME OF PRODUCT IN COMMERCE
176 systems
DISTRIBUTION
Nationwide

_____________________________
PRODUCT
i-STAT PT/INR Cartridge prothrombin time test in vitro diagnostic. Product list #’s 04J50-01 and 04J50-02, catalog # 420200; Ref 04J50-01 24, Recall # Z-0364-2007
CODE
Lot numbers: N06227, N06175A, N06176, N06179, N06181, N06186, N06188,, N06194, N06195A, N06200A, N06201A, N06201B, N06201C, N06202, N06206, N06206B, N06208, N06208A, N06209, N06222, N06222A, N06222B, N06223, N06227, N06227A, N06227B, N06235, N06235A, N06236A, N06236B, N06237, N06241, N06241A, N06241B, N06243, N06244, N06251, N06254, N06256, N06258C, N06262, N06263, N06265, N06265A, N06265B, N06265C, N06265D, N06265E, N06266, N06266A, N06267, N06268, N06268A, N06269, N06269A, N06273, N06274, N06274A, N06274B, N06274C, N06275, N06275A, N06275B, N06275C, N06276, N06277, N06277A, N06277B, N06282, N06285, N06285B, N06285C, N06290A, N06294, N06294A, N06295, N06298, N06298A, N06298B, N06301A, N06303, N06304, N06308, N06309, N06310A, N06311
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Point of Care Inc., East Windsor NJ, by letter on December 13, 2006.
Manufacturer: Abbott Point Of Care I Stat, Kanatakanata Ontario, Canada. Firm initiated recall is ongoing.
REASON
Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT PT/INR cartridges.
VOLUME OF PRODUCT IN COMMERCE
14,045 boxes of 24
DISTRIBUTION
Nationwide

_____________________________
PRODUCT
Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Item number MDS207060, Recall # Z-0365-2007
CODE
Lot number T502554397, size 6
RECALLING FIRM/MANUFACTURER
Terang Nusa Sdn Bhd, Kota Bharu, Malaysia, by telephone on December 13, 2006 and by letter dated December 20, 2006. Firm initiated recall is ongoing.
REASON
Some of the packages labeled as latex-free actually contain latex gloves.
VOLUME OF PRODUCT IN COMMERCE
43 cases
DISTRIBUTION
Nationwide and Internationally

_____________________________
PRODUCT
a) Philips Integris Allura x-ray systems angiographic - Allura 9 F/C
(floor and ceiling models). A mono-plane analog Allura with a
9" Image Intensifier, Recall # Z-0366-2007;
b) Allura Mono X-Ray System, angiographic - monoplane, analog Allura
with a 12" and 15" Image Intensifier, Recall # Z-0367-2007,
c) Allura FD 10 FC, X-Ray System, angiographic - a monoplane,
digital Allura FD (flat detector) with a 10" Image Intensifier (II),
Recall # Z-0368-2007;
d) Allura FD20 x-ray system, angiograph, monoplane, digital Allura FD
with a 20" detector FD, Recall # Z-0369-2007;
e) FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD,
10" detector, Recall # Z-0370-2007;
f) FD 20/10 X-Ray System, Angiograph, biplane, digital Allura FD, 10"
and 20" detectors, Recall # Z-0371-2007
CODE
a) thru f) Site numbers: 534928, 545964, 532207, 545365, 538387, 543397, 543398, 543399, 546572, 544581, 544728, 548147, 547005, 539456, 543953, 547234, 547364, 545838, 545839, 545840, 544395, 547952, 530393, 545799, 540790, 547431, 544122, 541659, 546060, 543433, 545604, 543198, 545921, 545640, 545966, 541590, 540456, 546201, 541572, 544130, 544635, 534665, 542963, 535303, 541783, 544631, 540930, 544610, 544506, 546456, 544989, 544990, 544992, 543984, 543759, 546906, 543873, 543087, 543108, 547279, 546908, 544750, 545518, 545052, 545539, 543799, 543411, 547660, 543229, 544371, 548288, 546668, 545714, 537604, 541046, 544513, 545583, 540808, 545280, 548039, 544489, 544120, 540275, 540284, 540952, 544637, 547855, 545941, 545753, 541597, 545025, 536030, 544543, 546693, 548140, 546025, 545752, 547976, 543971, 543972, 539634, 545749, 546119, 545750, 547642, 544433, 545069, 545073, 547777, 547321, 547628, 545733, 547392, 545293, 545296, 547908, 541880, 543386, 546013, 548061, 545282, 533398, 541588, 541589, 540374, 545357, 542486, 545443, 546012, 545090, 545037, 538432, 532226, 540407, 103281, 104950, 531926, 104953, 530653, 520630
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Philips, Bothell, WA, by letter dated December 12, 2006.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested.
VOLUME OF PRODUCT IN COMMERCE
140 devices
DISTRIBUTION
Nationwide

_____________________________
PRODUCT
GE Centricity PACS RA 1000 Workstation; for diagnostic image analysis; Software versions 2.1.XX. and 3.0.XX. used in combination with the GE Senographe 2000D, Senographe DS or Senographe Essential, Recall # Z-0373-2007
CODE
Versions 2.1.X.X. and 3.0.X.X.
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated January 12, 2007. Firm initiated recall is ongoing.
REASON
The Centricity PACS RA1000 Workstation Software may manifest certain mammography image display problems only if the images were acquired through GE Senographe versions 2000D, DS or Essential.
VOLUME OF PRODUCT IN COMMERCE
198 units
DISTRIBUTION
Nationwide and Internationally

_____________________________
PRODUCT
BIo-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes in two kits, Recall # Z-0376-2007
CODE
Diluent lot number AA61508, Catalog number for recalled diluent: 220-0119, expiration date 11/30/07 Catalog number for whole kit: 220-0201. Reorder pack lot numbers 2006 1537, 2006 1555, 2006 1561, 2006 1557, 2006 1597, 2006 1600, 2006 1745, 2006 2007. Expiration dates on hte above catalog numbers: 04/30/2007, except for 2006 1557, which is 2/28/07. The diluent is packaged with either HbA1c Calibrators (cat number 220-0128, lot number S61409, exp. date 5/31/2007), or HbA2/F/A1c calibrators (cat number 220-218, exp date 5/31/07. Calibrator diluent that comes with the kit has an expiration date of AA61408
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Hercules, CA, by
REASON
The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.
VOLUME OF PRODUCT IN COMMERCE
900 kits plus 43 sets of diluent
DISTRIBUTION
Nationwide and Internationally

_____________________________
PRODUCT
Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL, Recall # Z-0377-2007
CODE
Lot: U1546391
RECALLING FIRM/MANUFACTURER
Cook Urological, Inc., Spencer, IN, by letter dated January 5, 2007. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility, as the packages may not have been sealed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MA, ME, NH, and PR

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

__________________________________
PRODUCT
Medtronic Intersept Custom Tubing Pack. Do Not Reuse. The design and components of this product were specified by the user from an array of components and designs offered by the manufacturer. Any change in the cardiopulmonary bypass procedure that compromises the function of this Custom Tubing Pack is the responsibility of the user. The tubing is made of polyvinyl chloride (PVC). Portions of the tapered tubing are used in the vent, suction and arterial roller heads of the heart lung machine, Recall # Z-0340-7
CODE
Model / Lot Number: CB4W39R1 / 4876667; 0A84R2 / 4531036; 1708R18 / 4627100; 0V68R4 / 4212182; 1P07R6 / 4433014; 1P07R6 / 4678134; 2Y91R / 4628170; 2Y91R / 4800224; 2Y91R / 4902036; CB0Q49R14 / 4800849; 4D87R2 / 4184927
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by letter dated September 6, 2006.
Manufacturer: Medtronic Mexico, S. De R. L. De C. V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.
REASON
An out of specification condition exists with the tapered tubing found in some Custom Tubing Packs. The wall thickness is undersized and does not meet specifications.
VOLUME OF PRODUCT IN COMMERCE
146 packs
DISTRIBUTION
CA, FL, IL, IN, LA and TN

_____________________________
PRODUCT
Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, REF BOSL1L, Recall # Z-0378-2007
CODE
Lots 1055779, 1245930, 1263830, 1302670, 1310500, 1324570, 1351420, 1351480, G654810, G689730 and G726388
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Gary, IN, by letter dated December 15, 2006. Firm initiated recall is ongoing.
REASON
The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.
VOLUME OF PRODUCT IN COMMERCE
117 devices
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

_____________________________
PRODUCT
CopperSafe medication for lck, Velvet, and other external Parasites found on fish. 1 gallon containers, Recall # V-010-2007
CODE
Lot number WI621
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc., Fort Worth, TX, by telephone beginning on January 4, 2007. Firm initiated recall is ongoing.
REASON
After testing, product designed to treat, product designed to treat external parasites in ornamental fish was found to have unusual organoleptic properties.
VOLUME OF PRODUCT IN COMMERCE
324 one-gallon units
DISTRIBUTION
CA, OH, MI, NJ, FL, GA, IL, TX and NY

_____________________________
PRODUCT
O-NO-MORE (Formerly ORPHAN-NO-MORE) Calf Claimer Powder, packaged in 9-oz. bottles, For Animal Use Only, Recall # V-011-2007
CODE
A07
RECALLING FIRM/MANUFACTURER
Springer Magrath Co., McCook, NE, by telephone on January 11, 2007 and fax on January 12, 2007. Firm initiated recall is complete.
REASON
The bovine blood meal which was used to manufacture the finished product was cross-contaminated with prohibited bovine meat and bone meal, and the finished product is not labeled with the cautionary statement that it should not be fed to ruminants.
VOLUME OF PRODUCT IN COMMERCE
300/9-oz. bottles
DISTRIBUTION
NE

END OF ENFORCEMENT REPORT FOR JANUARY 31, 2007

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