Enforcement Report

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.

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December 27, 2006
06-52

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

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PRODUCT
Washington® Seafood Breading Mix, packaged in 2 lb. plastic bags, Recall # F-080-7
CODE
All 'Use By' dates from JAN 17 07 to NOV 03 07.
RECALLING FIRM/MANUFACTURER
Washington Quality Foods, Ellicott City, MD, by telephone and letter on November 10, 2006 and by press release on November 13, 2006. Firm initiated recall is ongoing.
REASON
Breading mix contains whey, a milk derivative which is not declared on the label. The mislabeled product may put allergic or milk sensitized consumers at risk for serious or life threatening allergic reactions.
VOLUME OF PRODUCT IN COMMERCE
159,072 units
DISTRIBUTION
MD, VA, DE, PA, NY, NJ, ME, MO, and NC.

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PRODUCT
Duncan Hines Bakery Style Chocolate Chip Muffin Mix, UPC Code: 6 44209 42012 4, Recall # F-081-7
CODE
Code located on top of carton: 27166523; 27266521; 27266522; 27266523; 31266522; 31266523; 06666622; 06666623
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pinnacle Food Corp., Mountain Lakes, NJ, by letters on October 17, 2006 and by press release on October 19, 2006.
Manufacturer: Barry Callebaut LLC, Saint Albans VT. Firm initiated recall is ongoing.
REASON
Chocolate chips contained milk. The finished Chocolate Chip Muffin Mix does not declare milk on the label.
VOLUME OF PRODUCT IN COMMERCE
14,880 cases
DISTRIBUTION
Nationwide

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

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PRODUCT
Reese Hollandaise Sauce (in glass jars) Nt. Wt. 7.5 oz. (212g) For Best Quality Refrigerate After Opening, UPC 0 70670 60108 1, Recall # F-078-7
CODE
Best By Date: June 22 2008 stamped on lid and outer shipping case.
RECALLING FIRM/MANUFACTURER
Recalling Firm: World Finer Foods, Inc., Bloomfield, NJ, by letter on August 28, 2006.
Manufacturer: Allied Old English Inc., Port Reading, NJ. Firm initiated recall is ongoing.
REASON
Hollandaise Sauce contains lactobacillus.
VOLUME OF PRODUCT IN COMMERCE
1264 cases of 12/7.5 oz. glass jars
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
Benzonatate Capsules USP, 100mg softgels, 100 count bottles, NDC 50111-851-01, Recall # D-414-7
CODE
Lot 24122208AA and 24122208B, Exp. 01/2007.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pliva, Inc., East Hanover, NJ, by letter on July 11, 2006.
Manufacturer: Banner Pharmacaps Inc, High Point, NC. Firm initiated recall is ongoing.
REASON
Failed Impurity Specification (6 and 9 month stability)
VOLUME OF PRODUCT IN COMMERCE
975,600 capsules
DISTRIBUTION
Nationwide

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PRODUCT
50% Urea Ointment, In a vehicle containing Vitamin E, Lactic Acid and Zinc, Rx only, Net Wt. 1.5 oz. (45g), For external use only, Not for ophthalmic use, NDC 68032-130-45, Recall # D-415-7
CODE
Lot # 5553 Exp: 5/08 Lot # 5554 Exp: 5/08 Lot # 5555 Exp 5/08
RECALLING FIRM/MANUFACTURER
Sonar Products, Inc., Carlstadt, NJ, by letter on October 16, 2006. Firm initiated recall is ongoing.
REASON
Degradation; product is crystallizing
VOLUME OF PRODUCT IN COMMERCE
30,084 tubes
DISTRIBUTION
GA

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PRODUCT
Docusate Sodium Softgel Capsules, 250 mg, 100 Softgel Capsules (10X10) unit dose package, NDC 62584-684-01; Also labeled under other brand name as Good Neighbor Pharmacy Extra Strength Stool Softener, Docusate Sodium 250 mg. capsule, 100 count bottle, NDC #24385-443-78, Recall # D-416-7
CODE
Lot #063677, lot #063677,
Lot #062130B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services Corp., Columbus OH, by letters on November 9 and November 28, 2006.
Manufacturer: Tishcon Corp., Westbury, NY. Firm initiated recall is ongoing.
REASON
Capsules are leaking.
VOLUME OF PRODUCT IN COMMERCE
4104/100 count unit dose packages & 5761/100 count bottles.
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

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PRODUCT
Human Tissue for Transplantation:
a) Achilles Tendon Frozen;
b) Patellar Ligament Hemi, Frozen;
c) Cartilage in Saline Vacuum;
d) Tibialis Anterior Tendon, Frozen
e) Tibialis Tendon Frozen;
f) Tibialis Tendon Posterior Frozen;
Recall # B-0114-7;
a) Fascia Lyo 101-150 sq cm;
b) Pericardium Lyo 26-50 sq cm;
c) ) Semitendonosus / Gracilis Frozen;
d) Patella Ligament Whole Frozen,
Recall # B-0115-7
CODE
a) 03-0178792, 03-0173682, 03-0168103, 03-0168104, 03-0162640, 03-0168841, 03-0181591, 03-0168302, 03-0179205, 03-0181592, 03-0042572, 03-0155372, 03-0182234, 03-0032401, 03-0174931, 03-0155371, 03-0161144, 03-0182782, 03-0182623, 03-0181628, 03-0182051, 03-0032400, 03-0168301, 03-0147962, 03-0173822, 03-0182235, 03-0181627, 03-0128130, 03-0162639, 03-0182783, 03-0182624, 03-0161143, 03-0182052, 03-0151503, 03-0147961, 03-0042571, 03-0179206, 03-0172621, 03-0135831, 03-0174932, 03-0173821, 03-0173681, 03-0172251, 03-0178791, 03-0173841, 03-0173842;
b) 03-0168842, 03-0181593, 03-0135832, 03-0181595, 03-0182781, 03-0178796, 03-0182625, 03-0182626, 03-0168844, 03-0173823, 03-0173825, 03-0179203, 03-0173826, 03-0182011, 03-0182049, 03-0179202, 03-0042574, 03-0139081, 03-0151502, 03-0147967, 03-0168102, 03-0162641, 03-0161142, 03-0128132, 03-0042575, 03-0168101, 03-0172618, 03-0181594, 03-0162643, 03-0168843, 03-0181438, 03-0172252, 03-0181596, 03-0178793, 03-0178794, 03-0032405, 03-0139084, 03-0179204, 03-0182047, 03-0181212, 03-0172620, 03-0182048, 03-0172617, 03-0172619, 03-0042573, 03-0042576, 03-0178795, 03-0139082, 03-0162644, 03-0173824, 03-0181213, 03-0172253, 03-0182050, 03-0151501, 03-0179201, 03-0181436, 03-0181437, 03-0032402, 03-00324404, 03-0162642, 03-0128131, 03-0128133, 03-0147968, 03-0181211;
c) 03-0014874, 03-0014871, 03-0014878, 03-0014875, 03-0014876, 03-0014877;
d) 03-0182053, 03-0182054, 03-0181621, 03-0179207, 03-0179208, 03-0181600, 03-0181599, 03-0168303, 03-0168304, 03-0155375, 03-0173846, 03-0173847, 03-0181622;
e) 03-0042582, 03-0042580, 03-0042581, 03-0178797, 03-0178798, 03-0178799, 03-0147963, 03-0147964, 03-0147965, 03-0147966;
f) 03-0155377, 03-0173845, 03-0182055, 03-0181623, 03-0155376, 03-0181598, 03-0181624, 03-0179209, 03-0181597, 03-0179210;

a) 03-0182237, 03-0182238, 03-0168105;
b) 03-0168845, 03-0173684, 03-168846, 03-0174935, 03-0174936, 03-0173683
c) 03-0147971;
d) 03-0182232, 03-0182233, 03-0155373, 03-0155374, 03-0179281, 03-0111812, 03-0174933, 03-0161141, 03-0173844, 03-0181625, 03-0173843
RECALLING FIRM/MANUFACTURER
DCI Donor Services Tissue Services Division, Nashville, TN, by letters on May 23, 2005. Firm initiated recall is ongoing.
REASON
Human tissue, which was either implicated in a post-transplant bacterial infection, or was processed in the same manner as tissue that was implicated in a post-transplant bacterial infection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
170 tissue allografts
DISTRIBUTION
New Mexico, TN, CA, NV, and AK.

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PRODUCT
Human Cadaveric Unprocessed Tissue, Recall # B-0420-7
CODE
A0501, A0502, A0503, A0504, A0505, A0506, A0507, B0501, B0502, B0503,
B0504, B0505, C0501, C0502, C0503, C0507, C0508, D0402, D0502, D0503,
D0504, D0505, D0509, E0401, E0402, E0403, E0404, E0405, E0406, E0407,
E0410, E0411, E0412, E0413, E0502, E0503, E0504, E0506, E0507, E0508,
E0509, E0510, E0511, F0401, F0402, F0405, F0407, F0408, F0410, F0411,
F0502, F0503, G0402, G0403, G0404, G0405, G0406, G0407, G0409, G0502,
G0503, H0401, I0401, I0402, I0403, J0401, J0402, J0403, J0404, J0405, J0406,
J0407, J0408, J0409, J0501, J0503, K0401, K0402, K0403, K0404, K0405,
K0501, K0502, K0503, K0504, K0505, L0401, L0403, L0404, L0405, L0406,
L0407, L0408, L0409, L0410, L0411, L0412, L0501
RECALLING FIRM/MANUFACTURER
Recalling Firm: Donor Referral Services, Raleigh, NC, by facsimile transmission dated June 30, 2006.
Alternate address: Hope of North Carolina, Raleigh, NC. Firm initiated recall is ongoing.
REASON
Human Tissues, recovered from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
99 units
DISTRIBUTION
FL and TX

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PRODUCT
Human Tissue for Transplantation, Recall # B-0421-7:
a) Achilles Tendon (various sizes), Fresh Frozen, Irradiated;
b) Cancellous Chips, Crushed 1-4mm/15 & 30cc, Freeze Dried, Irradiated;
c) Cancellous Chips 4-10mm/15cc, 30cc & 60cc, Freeze Dried, Irradiated;
d) Cancellous, Cortical Chips 1-4mm/30cc, Freeze Dried, Irradiated;
e) Cancellous Cubes 5-5mm/30cc, Freeze Dried, Irradiated;
f) Cloward Dowel (various sizes), Freeze Dried, Irradiated;
g) Cortical Plate 2x20cm, Freeze Dried, Irradiated;
h) Cortical Button 12x9mm, Freeze Dried, Irradiated;
i) Fascia Lata (various sizes), Freeze Dried, Irradiated;
j) Femoral Head w/Neck (various sizes), Fresh Frozen, Irradiated;
k) Femoral Ring 30mm, Fresh Frozen, Irradiated;
l) Femur Segment 6.0cm, Fresh Frozen, Irradiated;
m) Femur Shaft, Split 23cm, Fresh Frozen, Irradiated;
n) Fibula Ring 0.7cm, Freeze Dried, Irradiated;
o) Fibula Segment (various sizes), Freeze Dried, Irradiated;
p) Gracilis 0.7x28cm, Fresh Frozen, Irradiated;
q) Ilium Tricortical Block (various sizes), Freeze Dried, Irradiated;
r) Patella Tendon, Bisected (various sizes), Fresh Frozen, Irradiated;
s) Patella Tricortical 8x26mm, Freeze Dried, Irradiated;
t) Semitendonosus (various sizes), Fresh Frozen, Irradiated;
u) Tibialis Tendon Anterior (various sizes), Fresh Frozen, Irradiated;
v) Tibialis Tendon Posterior (various sizes), Fresh Frozen, Irradiated;
w) Tibial Shaft, Split (various sizes)
CODE
a) 05-0131-071, 05-0131-072, 05-0138-008, 06-0007-009, 06-0007-010,
06-0019-003;
b) 05-0129-001, 05-0129-002, 05-0129-004, 05-0129-005, 05-0129-007,
05-0129-008, 05-0131-040, 05-0131-041, 05-0131-042, 05-0131-043,
05-0131-044, 05-0131-045, 05-0131-046, 05-0131-047, 05-0131-048,
05-0131-049, 05-0138-023, 05-0138-024, 05-0138-025, 05-0138-026,
05-0139-014, 05-0139-016, 05-0139-017, 05-0139-018, 06-0007-015,
06-0007-016, 06-0007-017, 06-0007-018, 06-0019-017, 06-0019-018,
06-0019-020;
c) 05-0129-009, 05-0129-010, 05-0129-011, 05-0129-012, 05-0129-013,
05-0129-014, 05-129-015, 05-0129-016, 05-0129-017, 05-0131-019,
05-0131-020, 05-0131-021, 05-0131-022, 05-0131-023, 05-0131-024,
05-0131-025, 05-0131-026, 05-0131-027, 05-0131-028, 05-0131-029,
05-0131-030, 05-0131-031, 05-0138-027, 05-0138-029, 05-0138-030,
05-0138-032, 05-0139-019, 05-0139-020, 05-0139-021, 05-0139-022,
05-0139-023, 06-0007-019, 06-0007-020, 06-0007-021, 06-0007-022,
06-0007-023, 06-0007-024, 06-0019-022, 06-0019-023, 06-0019-024,
06-0019-025, 06-0019-026, 06-0019-027;
d) 05-0139-059, 05-0139-060, 05-0139-061, 05-0139-062, 05-0139-063,
05-0139-064, 05-0139-065, 05-0139-066, 05-0139-067, 05-0139-068;
e) 05-0131-014, 05-0131-015, 05-0131-016, 05-0131-017, 05-0131-018,
06-0007-025;
f) 05-0131-050, 05-0131-051, 05-0131-052, 05-0131-053, 05-0131-055,
05-0131-056, 05-0131-057, 06-0007-030;
g) 05-0138-011, 05-0138-012, 05-0138-013, 05-0139-001, 05-0139-002,
06-0007-035, 06-0007-037, 06-0019-016;
h) 05-0139-008;
i) 06-0007-013, 06-0007-014;
j) 05-0138-022, 05-0139-030, 05-0139-031, 06-0007-032, 06-0007-033;
k) 06-0019-009, 06-0019-010, 06-0019-011, 06-0019-012, 06-0019-013,
06-0019-014, 6-0019-015;
l) 05-0131-066, 05-0131-067, 05-0131-069, 05-0131-070;
m) 05-0129-025;
n) 05-0131-037, 06-0007-027, 06-0007-028;
o) 05-0131-036, 05-0138-018, 05-0138-020, 05-0138-021;
p) 06-0007-008;
q) 05-0131-032, 05-0131-033, 05-0131-034, 05-0131-075;
r) 05-0129-032, 05-0129-033, 05-0129-034, 05-0131-073, 05-0131-074,
06-0007-011, 06-0007-012;
s) 06-0007-031;
t) 05-0138-003, 06-0007-006;
u) 06-0007-001, 06-0007-002;
v) 06-0007-003, 06-0007-004;
w) 05-0139-003, 05-0139-005, 05-0139-006
RECALLING FIRM/MANUFACTURER
Alamo Tissue Services, Ltd., San Antonio, TX, by letters on June 28, 2006. Firm initiated recall is ongoing.
REASON
Human Tissues, recovered from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
161 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0303-7
CODE
Unit: C51493
RECALLING FIRM/MANUFACTURER
HCSC-Blood Center, Bethlehem, PA, by letter dated July 6, 2006. Firm initiated recall is complete.
REASON
Blood product, with no documentation to verify the irradiation process, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

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PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0359-7
CODE
Units: 26730-4974, 26730-5370, 26730-5569, 26730-5572, 26730-5834,
26730-5880, 26731-0691, 26731-0866, 26731-0962, 26731-1733,
26732-0271, 26732-0506, 26732-5191, 26732-5375, 26732-5381,
26732-5533, 26732-5573, 26732-5838, 26732-6222, 26732-6247,
26923-8476, 26923-8727, 26923-8883, 26923-9136, 26923-9152,
26923-9200, 26924-2377, 26924-2966
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on March 17, 2005, and by letter dated April 13, 2005. Firm initiated recall is complete.
REASON
Blood products, with undocumented quality control, were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
TX

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0399-7
CODE
Units: 268352557, 268352564, 268352541, 268351736, 268351756
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on September 22, 2005. Firm initiated recall is complete.
REASON
Red Cells, incorrectly tested for antibody to the Cytomegalovirus (CMV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
AR

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PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-0439-7;
b) Fresh Frozen Plasma (Apheresis), Recall # B-0440-7
CODE
a) Units: 71X27079-7 (distributed as split product);
b) Unit: 71X27079-7
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Brooksville, FL, by fax on October 14, 2005. Firm initiated recall is complete.
REASON
Blood Products, collected in an apheresis collection kit which was not used within an acceptable time period, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL

______________________________
PRODUCT
a) Red Blood Cells Leukocyte Reduced, Recall # B-0441-7;
b) Platelets, Recall # B-0442-7
CODE
a) and b) Unit: 9771326
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers Inc., Lake Park FL, by telephone on November 2, 2004 and follow-up letter dated December 12, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from the sexual partner of an immigrant from an HIV Group O risk area, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

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PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Recall # B-0449-7;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0450-7
CODE
a) Unit: 2060964-Part B;
b) Unit: 2060964-Part A
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone and facsimile transmission beginning on May 21, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0456-7
CODE
Unit number 5213589
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile dated March18, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0459-7;
b) Recovered Plasma, Recall # B-0460-7
CODE
a) and b) Unit: 4765590
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile dated April 5, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Oklahoma and Switzerland

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0461-7;
b) Recovered Plasma, Recall # B-0462-7
CODE
a) and b) Unit number 4900925
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile dated March 11, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Oklahoma and Switzerland

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0463-7;
b) Recovered Plasma, Recall # B-0464-7
CODE
a) and b) Unit number 5253844
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile dated July 7, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Oklahoma and Switzerland

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0465-07
CODE
Unit: 5418771
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on December 6, 2005. 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
OK

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0466-07;
b) Platelets, Recall # B-0467-07
CODE
a) and b) Unit number 5427132
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on October 17, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and NY

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0468-7
CODE
Unit: 5415359
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on October 13, 2005. 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
NJ

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0469-7;
b) Platelets, Recall # B-0470-7
CODE
a)) and b) Unit number 5319038
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N Goldman Center, Oklahoma City, OK, by facsimile September 16, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor who had traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and NY

______________________________
PRODUCT
Red Blood Cells, Recall # B-0473-7
CODE
Unit: 0341802
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on January 12, 2006. Firm initiated recall is complete.
REASON
Blood product, which tested positive for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0474-7;
b) Recovered Plasma, Recall # B-0475-7
CODE
a) and b) Unit: 0249958
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and facsimile beginning July 20, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and LA

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0476-7
CODE
Units: 9162127 (Parts 1, 2, & 3)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 28, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0477-7;
b) Platelets, Recall # B-0478-7;
c) Fresh Frozen Plasma, Recall # B-0479-7
CODE
a) and b) Units: 0247462, 0247463;
c) Unit: 0247463
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone or facsimile beginning July 25, 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
5 units
DISTRIBUTION
CA, LA, and MS

______________________________
PRODUCT
Recovered Plasma, Recall # B-0480-7
CODE
Unit: 5595312
RECALLING FIRM/MANUFACTURER
Associated Regional and University Pathologists, Salt Lake City, UT, by telephone and facsimile on July 31, 2006 and by letter dated July 31, 2006. Firm initiated recall is complete.
REASON
Blood product, which tested positive for the antibody to the human immunodeficiency virus (anti-HIV-1/2), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UT

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0481-7;
b) Platelets, Recall # B-0482-7;
c) Fresh Frozen Plasma, Recall # B-0483-7
CODE
a), b), and c) Unit 0253260
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and facsimile beginning July 25, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who may have been at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA and LA
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0484-7
CODE
Unit: 9038633
RECALLING FIRM/MANUFACTURE
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 14, 2006. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Micrococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
a) Plasma, Frozen, Recall # B-0487-7;
b) Platelets, Recall # B-0488-7;
c) Platelets, Irradiated, Recall # B-0489-7;
d) Fresh Frozen Plasma, Recall # B-0490-7;
e) Cryoprecipitated AHF, Recall # B-0491-7;
f) Plasma, Cryoprecipitate Reduced, Recall # B-0492-7
CODE
a) Units: 053T00998, 053FJ60413, 053FL83759, 053GC33836, 053FJ69159,
053GQ90858, 053V06428, 053L23590, 053FL87405, 053V12793, 053GV34992,
053KY57797, 053LR23002, 053GE52626, 053GZ13730, 053FE66059,
053GV43928, 053GC38832, 053R98339, 053GZ17003, 053FL06621,
053FQ87008, 053GV45742, 053FH97803, 053FK82140, 053FH03266,
053FH03288, 053GM29315, 053GZ11433, 053FE68691, 053FJ82837,
053FH83821, 053FP33303, 053R83415, 053FK68503, 053Y93812,
053GM28932, 053FH83914, 053GL10553, 053GC44246, 053H99311,
053Y99652, 053G34726, 053GE44214, 053V99715, 053FH91752,
053H92766, 053GR48998, 053LR22299, 053KL61924, 053H67185,
053FP26683, 053R72881, 053FC89372, 053FL77885, 053FN54600,
053KF47635, 053T81186, 053FP30725, 053L17367, 053V94953,
053FH82403, 053Q81341, 053FJ67338, 053GM29314, 053C09625,
053H76442, 053GF33296, 053GR29463, 053FR77274, 053FN63645,
053FX78996, 053FX78998, 053Y87468, 053GN44015, 053L28694,
053FE61463, 053FL91240, 053J67589, 053GV41286, 053R89408,
053GN46125, 053GM32634, 053GE56938, 053GJ24563, 053FQ83600,
053H84739, 053FP37460, 053FR80659, 053GL11891, 053FH89425,
053GZ15052, 053FE66070, 053FJ76138, 053GN47695, 053GM34037,
053C16941, 053FL01123, 053GF40669, 053LW26041, 053FN80052, 053T96282,
053FE69466, 053H91325, 053GZ17298, 053L43275, 053H91610, 053FP42254,
053FL06857, 053F38635, 053FM54868, 053FL07100, 053FN83492, 053FN84893,
053FR84327, 053FJ79762, 053GL14881, 053GH56427, 053H94176, 053V08603,
053V09796, 053FN89460, 053G60746, 053FF62120, 053FP46295, 053FQ91377,
053H98542, 053H98544, 053G62481, 053H99837, 053H85377, 053FL09085,
053FK66692, 053FH85641, 053FH85645, 053FL04907, 053GN50099, 053FE63453,
053FW28904, 053L23591, 053FM52598, 053FX94252, 053FJ63319, 053L46162,
053GC41652, 053GC41653, 053L46614, 053FQ89246, 053GV49544, 053F30655,
053GR27969, 053L21402, 053FE58529, 053GL07735, 053GH51476, 053GJ09338,
053FL78363, 053C09454, 053FK67223, 053GJ22951, 053FQ85009, 053FC06615,
053FL01071, 053GF26148, 053GH46211, 053T74939, 053V89571, 053KQ55835,
053T78386, 053GV34471, 053C05415, 053GQ77104, 053FL83769, 053H74356,
053GM28891, 053FN59832, 053FP33051, 053GR28777, 053FJ68022, 053FK64818,
053F32149, 053LL51104, 053GQ82381, 053Q83103, 053H78663, 053FX79009,
053FK67232, 053G44419, 053FK67996, 053T87968, 053FQ81269, 053FJ70933,
053GL09797, 053GE52625, 053L31341, 053FM47975, 053FN69978, 053M97774,
053GJ24548, 053GQ87659, 053FL96032, 053H85218, 053FQ84675, 053Y91094,
053F35761, 053F36686, 053FN76951, 053GJ28178, 053H90216, 053FH93820,
053FN80230, 053GF41411, 053FW24422, 053GZ17478, 053GC41203, 053LW27784,
053FC12581, 053H93010, 053LW27811, 053FQ87614, 053J76052, 053FL09222,
053C21698, 053FM57891, 053Y97459, 053GL16671, 053Q98458, 053GJ37121,
053J81669, 053KE37678, 053GN41030, 053GF35035, 053GZ12835, 053L33097,
053Q86592, 053GJ27209, 053GR38281, 053FN76817, 053F25071, 053R72923,
053FN59048, 053L23822, 053F32156, 053GQ83622, 053V02563, 053Y93074,
053LW31327, 053Y91115, 053V89918, 053FF55825, 053GR30840, 053FH85671,
053J68109, 053GZ14946, 053FK80334, 053FL09890, 053K35790, 053C13074,
053GQ74140, 053KL64537, 053FN76124, 053GV46476, 053H98440, 053T72990,
053GV51308, 053GE56103, 053FM49193, 053KS40230, 053GS28868, 053C07442,
053FP33063, 053FQ80874, 053F33658, 053R88733, 053G49874, 053V02232,
053G51026, 053FQ84986, 053GL13105, 053LL56095, 053FR82296, 053GF40643,
053R98327, 053FP41397, 053Y94165, 053J76381, 053C21109, 053FE73321,
053FF61296, 053FJ85497, 053FC84490, 053GR26913, 053FM44094, 053R83261,
053FL95265, 053FL98529, 053GN47628, 053FL01041, 053H99753, 053GJ10619,
053FE55123, 053Q80987, 053Q81352, 053H93837, 053FC17232, 053FJ59510,
053V91042, 053KQ56499, 053FQ73909, 053GE47328, 053GL07862, 053FK67356,
053T87539, 053GM31417, 053GL11388, 053FN76819, 053GF39571, 053FJ77722,
053GC41200, 053GZ17796, 053FK80068, 053FR84423, 053FQ88070, 053GC42655,
053GQ03951, 053J59196, 053GL04920, 053GZ11961, 053FQ81966, 053G47708,
053V00535, 053Y92412, 053T97538, 053GE70103, 053GF43068, 053GV46476,
053FJ82840, 053V12813, 053GJ38167, 053GM29294, 053R95762, 053V06436,
053KX36398, 053R81953, 053FF55187, 053GR28857, 053GQ82386, 053FL01067,
053FH96325, 053J79757, 053Y99157, 053L36603, 053FE53486, 053GV35037,
053FK84053, 053LR22689, 053R95162, 053FE71521, 053GF26134, 053F32724,
053Q89114, 053FC19598, 053LW18453, 053GV39746, 053FL90658, 053Y88060,
053GC35908, 053FP38385, 053FL98082, 053FQ89238, 053FP24154, 053GF26132,
053FL85288, 053C11941, 053GJ21330, 053GE52343, 053GL09868, 053GC35914,
053FE63304, 053V01191, 053GR36327, 053GL13327, 053GM34039, 053GM34040,
053FN76880, 053GR39039, 053L42575, 053GZ17091, 053FE69796, 053R01863,
053FR84019, 053FE71650, 053FQ88080, 053GC42411, 053FL09745, 053GV49072,
053Q99340, 053GE75859, 053FJ67331, 053GM29295, 053GM29316, 053G42789,
053FK66097, 053GM43527;
b) Units: 053GC33836, 053GJ16939, 053FF54505, 053LW18453, 053FX78703,
053FC96608, 053L33097, 053FN59048, 053LW24766, 053FK64818, 053GE56042,
053R83415, 053T72990, 053GZ11181, 053L25685, 053FC01547, 053GR34316,
053FK67996, 053T74939, 053FC03532, 053R95162, 053FL83759, 053FH83914,
053GC42212, 053J59130, 053H93188, 053L22043, 053G42789, 053R84150,
053J64133, 053Q86445, 053FC07547, 053FK67223, 053FK67232, 053Y91094,
053R01679, 053GE46489, 053FN68332, 053GM39065, 053GJ27209, 053GR28777,
053G47708, 053GE56938, 053FC03537, 053GE70103, 053R72881, 053KF47635,
053GV34992, 053C07442, 053F30655, 053Y94618, 053G58274, 053KQ55835,
053FN57710, 053GV39485, 053Y87054, 053R01863, 053GC41203, 053T81186,
053C09454, 053GM30775, 053FX85115, 053L46162, 053FM49798, 053GV49072,
053H85218, 053GZ11587, 053R88733, 053GL14881, 053FW28904, 053L43047,
053GZ10534, 053FC01389, 053Y94165, 053FX91370, 053GE65689, 053GV34471,
053GR27969, 053FL87033, 053KS40230, 053GJ10619, 053L17367, 053Q81855,
053FP33918, 053GE48706, 053H83477, 053GL11891, 053T92384, 053LW25299,
053FN83525, 053FL09890, 053FM57891, 053Y00020, 053KQ56499, 053R72923,
053GS28868, 053T82866, 053GJ15444, 053V94953, 053FC93750, 053L21402,
053GE47470, 053H77545, 053FF56365, 053L35849, 053FH93455, 053C20514,
053FM48806, 053FN69978, 053FL96032, 053GC37919, 053FX94476, 053LW15877,
053GJ09673, 053G60746, 053FH82403, 053LL53568, 053H93714, 053FN89460,
053GL00834, 053LW18690, 053K36217, 053J75215, 053L45359, 053GR48037,
053GR26913, 053FQ78134, 053G56599, 053GL09797;
c) Units: 053FN84893, 053Q82647, 053GJ30877;
d) Unit: 053FC89525;
e) Units: 053F28365, 053FC89525, 053FY23113, 053Q78528, 053C05631;
f) Unit: 053FC89525
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by letter beginning April 8, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed
VOLUME OF PRODUCT IN COMMERCE
543 units
DISTRIBUTION
IL, MD, NY, NC, PA, VA, and D.C

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0514-7;
b) Fresh Frozen Plasma, Recall # B-0515-7
CODE
a) and b) Unit: 22GS24166
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on July 27, 2006 and by follow-up letter dated August 2, 2006. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of Platelets that was possibly contaminated with gram positive cocci, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA and NJ

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0297-7
CODE
Unit: 172046504
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., McAllen, TX, by letter dated November 11, 2005. Firm initiated recall is complete.
REASON
Blood product, with an un-verified platelet count, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0435-7
CODE
Units: 71X183444
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile transmission dated July 19, 2005.
Manufacturer: LifeSouth Community Blood Centers, Inc., Huntsville, AL. Firm initiated recall is complete.
REASON
Platelets, not manufactured according to manufacturer’s specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0438-7
CODE
Unit: 16GY05430
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on February 10, 2006 and follow-up letter dated February 13, 2006. Firm initiated recall is complete.
REASON
Blood product, mislabeled as to antigen phenotype, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced, Recall # B-0453-7;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0454-7
CODE
Unit: 21KP60583
RECALLING FIRM/MANUFACTURER
American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on June 27, 2004, and by letter dated June 29, 2004. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Staph species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR

______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0472-7
CODE
Units 16383-2263 (split unit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated September 27, 2005.
Manufacturing Firm: Blood Systems, Inc., dba United Blood Services, Meridian, MS. Firm initiated recall is complete.
REASON
Blood products, for which documentation of the apheresis procedure was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS

______________________________
PRODUCT
Red Blood Cells, Recall # B-0485-7
CODE
Unit: 4521100
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St. Petersburg, FL, by facsimile on July 28, 2006. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly tested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
____________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0486-7
CODE
Units: FE64838, FE68696, FE65301, FG45140, FG27179, FG54292, FG53414, FG80202, FG73371, FH42762, FH40598, FH29132, FH36123
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on July 7, 2006. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood with an extended collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
IL and IN

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0512-7
CODE
Units 9302197 (parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 3, 2006. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

______________________________
PRODUCT
a) One Touch Basic/Profile Blood Glucose test strips, Recall # Z-0261-2007;
b) One Touch Ultra Blood Glucose Test Strips, Recall # Z-0262-2007
CODE
a) Lot Numbers: 2619932, 2606340;
b) Lot Number: 2691191
RECALLING FIRM/MANUFACTURER
Medical Plastics Devices Inc, Point Claire, Quebec, Canada, by telephone on October 17, 2006 and by letter on October 18, 2006. Firm initiated recall is ongoing.
REASON
Counterfeit Glucose Test Strips.
VOLUME OF PRODUCT IN COMMERCE
3353 boxes
DISTRIBUTION
Nationwide

______________________________
PRODUCT
OneTouchBasic/Profile and OneTouch Ultra- Blood Glucose test strips. For use with ONE TOUCH Brand Meters, Recall # Z-0263-2007
CODE
OneTouch Ultra, Lot 2691191 and 2691261. OneTouch, Lot 2615211
RECALLING FIRM/MANUFACTURER
Milwaukee Notions, Inc., Union Grove, WI, by telephone beginning October 10, 2006. Firm initiated recall is ongoing.
REASON
Counterfeit
VOLUME OF PRODUCT IN COMMERCE
1,512 OneTouch Ultra and 183 OneTouch basic
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER Delivery System, Order no. 9-DEL-5F-180/60, 9-DEL-6F-45/60, 9-DEL-6F-180/80, 9-DEL-7F-45/60, 9-DEL-7F-45/80, 9-DEL-7F-180/80, 9-DEL-8F-45/60, 9-DEL-8F-45/80, 9-DEL-8F-180/80, 9-DEL-9F-45/80, 9-DEL-9F-180/80, 9-DEL-10F-45/80, 9-DEL-12F-45/80. [Breakdown of order no. '9-DEL-5F-180/60' is as follows: 9-DEL, French size (5F) - degree angle curve (180) / usable length in cm (60).] b) the following devices are not approved for US distribution: AMPLATZER TorqVue Delivery System, order no. 9-ITV06F45/60, 9-ITV07F45/60, 9-ITV07F45/80, 9-ITV08F45/60, 9-ITV08F45/80, 9-ITV09F45/80, 9-ITV10F45/80, 9-ITV12F45/80, 9-ITV05F180/60, 9-ITV06F180/80, 9-ITV07F180/80, 9-ITV08F180/80, 9-ITV09F180/80. The Delivery System is comprised of a delivery sheath, delivery cable, dilator, loading device and pin vise, Recall # Z-0255-2007;
Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as follows: a) AMPLATZER Exchange System, Order no. 9-EXCH-6F-180/80, 9-EXCH-8F-180/80, 9EXCH-9F-45/80, 9-EXCH-12F-45/80. [Breakdown of order no. '9-EXCH-6F180/80' is as follows: 9-EXCH, French size (6F) - degree angle curve (180) / usable length in cm (80).] and b) the following devices are not approved for US distribution: AMPLATZER TorqVue Exchange System, Order no. 9-EITV09F45/80, 9-EITV12F45/80, 9-EITV06F180/80, 9-EITV08F180/80. The Exchange System is comprised of a delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0256-2007;
AMPLATZER TorqVue (cardiac septal occluder) Delivery System with Pusher Catheter Order no. 9-TVSP7F-180/80, 9-TVSP8F-180/80, 9-TVSP9F-180/80. [Breakdown of order no. '9-TVSP-7F-180/80' is as follows: 9-TVSP, French size (7F) - degree angle curve (180) / usable length in cm (80).] Sterile EO. Single Use Only. CAUTION: Investigational device limited by U.S. Law to Investigational Use. The AMPLATZER TorqVue Delivery System with Pusher Catheter consists of a radiopaque delivery sheath, translucent loading device, dilator, plastic vise, delivery cable, and pusher catheter. The delivery system also includes a high pressure Hemostasis valve with a swivel luer connector. The loading device, also with a full thread swivel luer connector, allows a positive fit and seal between sheath and loader. The translucent loader allows for visualization of the device and potentially the presence of air during transfer of device to the sheath, Recall # Z-0257-2007
CODE
a) Order no. 9-DEL-5F-180/60, Lot Numbers: M03J19-05, M03L18-49, M04B02-02, M04C01-19, M04E18-13, M04J13-15, M04L02-04, M04M28-10, M05C15-31, M05C25-27, M05D29-51, M05G20-44, M05G28-19, M05H30-45, M05J23-32. Order no. 9-DEL-6F-45/60, Lot Numbers: M03L11-45, M03J23-04, M04B09-16, M04E27-19, M04L22-12, M05A03-10, M05B04-20, M05B08-04, M05C08-23, M05C09-05, M05E24-48, M05H01-51, M05J12-16, M06C20-25, M06D03-02, M06D19-71, M06E22-46. Order no. 9-DEL-6F-180/80, Lot Numbers: M03K16-22, M03K28-33, M03L11-47, M03M02-09, M03M03-09, M03M12-18, M04A19-31, M04B03-10, M04C01-17, M04C23-12, M04D06-10, M04D13-16, M04E24-16, M04F23-21, M04F28-40, M04G01-22, M04G27-27, M04H03-17, M04H12-11, M04H24-23, M04L08-02, M04M16-21, M04M30-04, M05A03-09, M05A05-27, M05A12-07, M05A17-07, M05A18-04, M05A20-09, M05A27-27, M05A31-06, M05B02-26, M05B21-13, M05B23-09, M05C08-04, M05C25-02, M05D07-08, M05D13-09, M05D14-13, M05G07-20, M05G11-03, M05G12-06, M05G15-24, M05G15-31, M05G27-41, M05H08-19, M05H04-10, M05H05-29, M05H09-09, M05K14-06, M05K20-10, M05K28-02, M05M28-23, M06A13-17, M06D19-53, M06D19-57, M06D19-55, M06D19-59, M06E16-68, M06E22-65, M06E22-67, M06F07-90, M06F13-86. Order no. 9-DEL-7F-45/60, Lot Numbers: . Order no. , Lot Numbers: M03L12-09, M04C23-09, M04E24-17, M04G01-24, M04M10-18, M05B04-18, M05B07-06, M05B16-02, M05D08-09, M05F13-11, M05G15-16, M05G19-24, M05J08-03. Order no. 9-DEL-7F-45/80, Lot Numbers: M03J19-07, M03K14-06, M03K28-35, M03L11-48, M04B03-09, M04B03-14, M04C08-12, M04D06-12, M04E11-28, M04E24-20, M04F08-23, M04H03-23, M04J17-07, M04K07-02, M04K28-06, M04L30-04, M05A11-12, M05A11-10, M05A12-05, M05B04-09, M05B16-04, M05B16-23, M05B23-07, M05C10-07, M05C14-07, M05C15-29, M05D04-15, M05E03-02, M05E12-16, M05E12-03, M05E16-21, M05E17-45, M05F01-02, M05F30-25, M05G07-02, M05G21-06, M05G29-23, M05H01-11, M05H17-09, M05J16-13, M05J16-68, M05J28-08, M05K04-04, M05M05-11, M06A13-19, M06C20-23, M06C28-42, M06D04-77, M06D12-20, M06E16-80, M06F01-43, M06F07-88, M06F13-76, M06G25-96. Order no. 9-DEL-7F-180/80, Lot Numbers: M03K24-14, M03L12-10, M03M12-19, M03G15-34, M04B03-08, M04B09-17, M04C01-18, M04D01-05, M04D06-11, M04D20-07, M04E04-05, M04F08-21, M04H03-18, M04H24-25, M04K22-13, M04L30-12, M04M13-05, M05A18-26, M05A20-11, M05B08-06, M05B14-22, M05B18-10, M05B18-12, M05C16-33, M05C16-18, M05D05-39, M05E11-30, M05E18-04, M05E26-23, M05G08-07, M05G15-29, M05G26-16, M05H02-22, M05H03-11, M05J13-14, M05J19-66, M05J23-07, M05J26-19, M05K19-04, M05L30-22, M05M22-20, M06D19-67, M05D19-69, M06E16-76, M06E22-71, M06E22-69. Order no. 9-DEL-8F-45/60, Lot Numbers: M03K14-07, M03L18-50, M03M03-11, M04C23-10, M04E24-18, M04G01-20, M04L30-02, M04M15-20, M05B07-08, M05B14-04, M05B15-07, M05B24-14, M05B25-06, M05H19-13. Order no. 9-DEL-8F-45/80, Lot Numbers: M03J19-08, M03J25-27, M03K09-23, M03K28-36, M03L11-46, M03M03-12, M03M29-07, M04A19-28, M04A28-16, M04B03-13, M04B09-19, M04B17-33, M04B24-08, M04C23-11, M04D06-13, M04D26-06, M04D26-10, M04F08-22, M04F27-47, M04H24-22, M04J07-09, M04J10-22, M04J17-08, M04J17-09, M04K06-02, M04K11-08, M04K15-10, M04K25-25, M04L02-02, M04L08-12, M04L29-18, M04M01-02, M04M10-08, M04M20-16, M04M22-02, M04M30-05, M05A11-08, M05A18-28, M05A21-20, M05A21-24, M05A24-34, M05A27-13, M05A28-13, M05A31-08, M05B17-04, M05B17-06, M05C21-24, M05C24-04, M05C25-18, M05C30-24, M05C31-28, M05D06-07, M05D12-03, M05D14-09, M05D20-06, M05D25-19, M05D27-20, M05D28-13, M05E24-17, M05E25-21, M05E27-46, M05F06-46, M05F21-43, M05F21-41, M05G20-10, M05G27-39, M05H12-16, M05H17-13, M05H24-19, M05J09-10, M05J09-12, M05K11-03, M05K18-10, M05K20-08, M05K21-05, M05L17-19, M05L21-04, M05L28-04, M05L30-20, M06A09-15, M06A12-10, M06A12-12, M06A20-25, M06A20-27, M06A24-18, M06A20-29, M06C17-36, M06C17-38, M06D04-73, M06D11-05, M06D12-12, M06D12-14, M06D12-16, M06D12-18, M06E22-49, M06E22-51, M06F01-47, M06F07-82, M06F07-84, M06F07-86, M06F13-72, M06F13-74, M06F22-19, M06F29-12, M06G24-46. Order no. 9-DEL-8F-180/80, Lot Numbers: M03L18-52, M04B09-18, M04C23-13, M04E27-20, M04F08-24, M04H03-20, M04K26-18, M04L04-17. M05B11-08, M05C01-06, M05C01-08, M05C11-02, M05E02-21, M05F28-12, M05J01-38, M05J22-28, M05K18-04. Order no. 9-DEL-9F-45/80, Lot Numbers: M03K14-08, M03K24-15, M03K28-37, M03M02-12, M03M03-08, M03M29-03, M03M29-06, M03M30-13, M04A19-29, M04A28-18, M04B03-12, M04B17-38, M04C08-13, M04C15-04, M04C15-06, M04D06-09, M04D13-17, M04D20-08, M04D26-07, M04D26-09, M04E24-19, M04E27-24, M04F21-43, M04F23-23, M04G27-25, M04H12-12, M04H24-20, M04J22-13, M04K08-02, M04L05-08, M04L19-11, M04L29-02, M04L29-17, M04L29-23, M04L30-10, M04M14-02, M04M14-04, M04M14-21, M04M16-23, M04N22-23, M05A05-25, M05A03-12, M05A11-06, M05A13-19, M05A18-24, M05A19-04, M05A24-09, M05A24-32, M05A24-36, M05A25-19, M05A28-11, M05B01-05, M05B02-24, M05B04-22, M05B10-05, M05B11-06, M05B22-03, M05B23-05, M05B24-20, M05C10-25, M05C15-27, M05C24-02, M05D04-13, M05D06-05, M05D07-04, M05D08-11, M05D12-20, M05D26-26, M05E11-14, M05E11-16, M05E13-09, M05E31-04, M05E31-10, M05E31-12, M05F06-44, M05F03-12, M05F09-06, M05F10-07, M05F14-26, M05F16-17, M05F27-06, M05F29-06, M05G06-07, M05G18-30, M05G19-15, M05G27-07, M05G27-43, M05H01-09, M05H12-14, M05H18-34, M05H19-08, M0530-36, M05J07-10, M05J08-05, M05J16-57, M05L01-02, M05L18-02, M05L30-06, M05M02-21, M05M06-13, M05M08-16, M05M22-12, M05M22-16, M06A09-12, M06A16-23, M06C15-52, M06C20-27, M06C24-22, M06D04-69, M06D04-71, M06D19-61, M06D19-63, M06D21-03, M06D21-05, M06D21-07, M06E22-53, M06E22-55, M06F13-78, M06F29-10, M06G25-93. Order no. 9-DEL-9F-180/80, Lot Numbers: M03K28-34, M03L18-51, M04L22-14, M05C28-12, M05D07-10, M05E03-13, M05F22-09, M05J26-21. Order no. 9-DEL-10F-45/80, Lot Numbers: M03J25-26, M03K01-02, M03K09-22, M03K14-05, M03K16-16, M03K16-17, M03K24-09, M03L18-56, M03M30-11, M03M30-14, M03M30-15, M04A19-30, M04B03-11, M04B17-34, M04B24-09, M04C30-08, M04F08-20, M04F23-20, M04F28-46, M04G01-19, M04G01-21, M04H23-20, M04H23-21, M04J07-04, M04L29-19, M04L29-20, M04M22-25, M04M17-19, M04M29-09, M04M29-10, M05A03-11, M05A10-07, M05A10-09, M05A14-08, M05B07-24, M05B07-25, M05B07-26, M05B18-06, M05B21-04, M05B24-08, M05C03-08, M05C07-06, M05C10-05, M05C10-27, M05C15-25, M05C23-07, M05C29-13, M05D29-05, M05E04-17, M05E05-24, M05E09-19, M05E09-21, M05E16-19, M05E17-43, M05E24-13, M05E27-38, M05E26-33, M05F09-08, M05F28-08, M05F28-10, M05H03-37, M05H22-06, M05H25-15, M05H25-13, M05J01-13, M05J22-23, M05K10-07, M05K13-04, M05K19-02, M05K21-03, M05L18-04, M05L29-12, M05M02-23, M05M01-05, M05M22-18, M06A13-15, M06C15-55, M06C24-20, M06D04-65, M06D04-67, M06E08-10, M06E08-12, M06F07-80, M06F13-82, M06G25-94. Order no. 9-DEL-12F-45/80, Lot Numbers: M03J25-28, M03K16-21, M03K24-13, M03L18-55, M03M03-13, M03M30-12, M03M30-16, M04A28-19, M04C09-03, M04C09-04, M04C15-05, M04D01-04, M04D06-08, M04D26-08, M04F21-42, M04F23-22, M04G27-26, M04H03-22, M04H24-21, M04J30-02, M04K05-02, M04K25-23, M04L04-09, M04M10-05, M04M23-02, M05A13-03, M05A14-11, M05A19-06, M05B04-24, M05B21-28, M05C03-04, M05C02-06, M05C07-08, M05C08-02, M05C21-25, M05D07-06, M05D15-28, M05D19-02, M05D18-45, M05D25-04, M05D28-23, M05D29-19, M05E02-08, M05E10-29, M05E13-26, M05E19-07, M05E20-17, M05E24-15, M05F07-12, M05F15-35, M05F15-43, M05F20-05, M05F21-54, M05G13-16, M05G25-15, M05G27-09, M05H05-27, M05H26-08, M05H29-16, M05J09-27, M05J12-09, M05J12-07, M05K06-10, M05K07-25, M05K31-28, M06C15-57, M06D04-75, M06D12-10, M06E16-78, M06F01-45, M06F13-84. the following devices are not approved for US distribution: AMPLATZER TorqVue Delivery System, order no. 9-ITV06F45/60, Lot numbers: M05K24-25, M05L03-06, M06C03-17, M06C27-05, M06E22-57. Order no. 9-ITV07F45/60, Lot numbers: M05K24-27, M05L04-13, M06B10-21, M06E01-40, M06F13-96. Order no. 9-ITV07F45/80, Lot numbers: M05K24-04, M05L10-07, M05L14-13, M05L15-34, M06B01-31, M06C02-14, M06F01-33, M06F07-68, M06F07-70. Order no. 9-ITV08F45/60, Lot numbers: M05K24-29, M05L03-08, M06B10-25. Order no. 9-ITV08F45/80, Lot numbers: M05K24-31, M05L11-15, M05M06-17, M05M07-10, M05M12-16, M06A05-25, M06B01-33, M06B10-27, M06B10-23, M06E03-10, M06E03-08, M06E16-84, M06F01-41, M06F13-90, M06G06-18, M06G25-79. Order no. 9-ITV09F45/80, Lot numbers: M05K24-33, M05L10-09, M05M12-18, M05M12-20, M06A12-19, M06B01-37, M06B10-29, M06C03-14, M06C10-18, M06C10-20, M06C13-38, M06C13-40, M06D19-73, M06D26-26, M06D26-28, M06D26-30, M06F01-39, M06F07-76, M06F07-72, M06F13-98, M06F14-03, M06F22-17, M06F14-01, M06G24-28, M06F22-15. Order no. 9-ITV10F45/80, Lot numbers: M05K24-06, M05L02-12, M05M07-12, M05M12-22. M06B01-39, M06C02-16, M06C10-22, M06C10-24, M06C13-42, M06C13-44, M06D12-08, M06D12-06, M06F13-92, M06G06-24, M06G06-22. Order no. 9-ITV12F45/80, Lot numbers: M05K24-35, M05L14-09, M05M05-15, M05M12-24, M06B01-41, M06C02-18, M06C20-39, M06C10-28, M06C10-26, M06D12-01, M06E03-04, M06E09-59, M06G25-89. Order no. 9-ITV05F180/60, Lot numbers: M05K24-02, M05L02-15, M06C27-07. Order no. 9-ITV06F180/60, Lot numbers: Order no. 9-ITV06F180/80, Lot numbers: M05K24-08, M05L03-10, M05L04-15, M05L17-23, M05L28-03, M06C20-29, M06C20-31, M06C27-08, M06C20-33, M06E01-05, M06G06-26. Order no. 9-ITV07F180/80, Lot numbers: M05K24-10, M05L08-06, M05L15-28, M05L17-25, M06B17-34, M06B21-43, M06B21-45, M06B21-47, M06G24-24. Order no. 9-ITV08F180/80, Lot numbers: M05K24-23, M05L11-17, M06B17-28, M06D19-65, M06E08-05. Order no. 9-ITV09F180/80, Lot numbers: M05K24-21, M05L07-06, M06B17-32;
b) Order no. 9-EXCH6F-180/80, Lot Numbers: M05F10-13, M06F22-25. Order no. 9-EXCH8F-180/80, Lot numbers: M04D01-06, M04E27-21, M05C23-13. Order no. 9EXCH9F-45/80, Lot Numbers: M03L18-54, M05A12-09, M05D19-10, M05D18-47, M05E23-37, M05G15-06, M05H18-36. Order no. 9-EXCH12F-45/80, Lot Numbers: M05A13-23, M05B04-11, M05B14-08, M05C30-11, M05E02-19, M05H08-20. The following devices are not approved for US distribution: AMPLATZER TorqVue Exchange System, Order no. 9-EITV09F45/80, Lot numbers: M06A05-31, M05L15-24. Order no. 9-EITV12F45/80, Lot numbers: M06A05-33, M05L15-26. Order no. 9-EITV06F180/80, Lot numbers: M06D19-51. Order no. 9-EITV08F180/80, Lot numbers: M05L15-32, M06G26-02;
c) Order no. 9-TVSP7F-180/80, Lot Numbers: M03K16-18, M03K24-10, M03K28-30, M03L06-36, M03L12-04, M03M02-10, M04B17-36, M04E18-12, M04E27-16, M04H31-16, M04L15-16, M05C09-09, M05C25-06, M05D20-17, M05E05-20, M05E23-39. Order no. 9-TVSP8F-180/80, Lot Numbers: M03J17-08, M03K16-19, M03K24-11, M03K28-31, M03L06-37, M03L12-05, M03M02-11, M03M30-10, M04B17-37, M04E27-17, M04L08-10, M05A13-05, M05C25-08, M05E05-07, M05F17-10. Order no. 9-TVSP9F-180/80, Lot Numbers: M03J17-09, M03K16-20, M03K24-12, M03K28-32, M03L06-38, M03L12-06, M04E27-18, M04H03-21, M04L15-18, M05D11-12, and M05D20-19.
RECALLING FIRM/MANUFACTURER:
AGA Medical Corporation, Golden Valley MN, by facsimile or e-mail dated September 29, 2006. Firm initiated recall is ongoing
REASON
AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier. AGA has no confirmed complaints or adverse events related to this failure mode.
VOLUME OF PRODUCT IN COMMERCE
107,484 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Invasive Blood Pressure Interface Cables: a) Medrad 9500 Multigas monitor for MRI,
Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira
IBP Transducer b) Invasive Blood Pressure Interface Cable (Part # 3008772) for use
with Braun IBP Transducers. The product is an accessory to patient physiological
monitor, Recall # Z-0258-2007;
b) Veris Invasive Blood Pressure Interface Cables-Part # 3010478.
The product is an accessory to patient physiological monitor, Recall # Z-0259-2007
CODE
a) and b) Catalog number 3006314, 3010478, and 3008772
RECALLING FIRM/MANUFACTURER
Medrad Inc, Indianola, PA, by telephone and letter dated November 20, 2006. Firm initiated recall is ongoing.
REASON
Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4 RF (model H230), and CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), Recall # Z-0269-2007
CODE
Model H210, Serial numbers: 204765, 204766, 204767, 204769, 204770, 204771, 204772, 204773, 204774, 204777, 204784, 205492, 205494, 205495, 205497, 205498, 205504, 205507, 205512, 205523, 205525;
Model H215, Serial numbers: 703984, 703985, 703986, 704415, 704417, 704418, 704421, 704422, 704423, 704424, 704425;
Model H217, Serial numbers: 704509, 704531, 704534, 704545, 704547, 704550, 705267, 705294, 705335, 705350;
Model H219, Serial numbers: 203320, 203344, 203355, 203377, 203382;
Model H230, Serial numbers: 201149, 201150, 201151, 201152, 201153, 201154, 201155;
Model H239, Serial numbers: 650451, 650453, 650454
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, Saint Paul, MN, by letter, dated October 9, 2006.
Manufacturer: Guidant-Ireland, Clomel, County Tipperary, Ireland. Firm initiated recall is ongoing.
REASON
Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the shocking vector has changed.
VOLUME OF PRODUCT IN COMMERCE
57 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber catheter.
Latex Free A Port Ref Product No. AP-01007; Recall # Z-0270-2007;
b) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Ref Product No. AP-01013 Latex-Free Low Profile Port, Recall # Z-0271-2007;
c) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A(2) Port, 17 Fr. Introducer Kit REF Product No. AP-06535, Recall # Z-0272-2007;
d) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A(2) Port, 10 Fr. Introducer Kit Ref Product No. AP-06530, Recall # Z-0273-2007;
e) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A(2) Port , 12 Fr. Introducer Kit. Ref Product Code: AP-06528,
Recall # Z-0274-2007;
f) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A Port, 10 Fr. Introducer Kit. Ref Product No. AP-06520,
Recall # Z-0275-2007;
g) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile B Port, 6 Fr. Introducer Kit. Ref Product No. AP-06046,
Recall # Z-0276-2007;
h) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 10 Fr. Introducer Kit. Ref Product No. AP-06042,
Recall # Z-0277-2007;
i) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 9 Fr. Introducer Kit. Ref Product No. AP -06040,
Recall # Z-0278-2007;
j) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 6 Fr. Introducer Kit Ref. Product No. AP-06036,
Recall # Z-0279-2007;
k) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 10 Fr. Introducer Kit Ref Product No. AP-06022,
Recall # Z-0280-2007;
l) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 9 Fr. Introducer Kit Ref Product No. AP-06020,
Recall # Z-0281-2007;
m) Implantable Vascular Access system --Infusion Ports with Silicone Rubber Catheter.
Latex-free A Port. 9 Fr. Introducer Kit. Ref. Product No. AP-06018, Recall # Z-0282-2007;
n) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 6 Fr. Introducer Kit. Ref. Product No. AP-06016,
Recall # Z-0283-2007;
o) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-free A Port. 10 Fr. Introducer Kit. Ref. Product No. AP-06015, Recall # Z-0284-2007;
p) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free A Port. 6 Fr. Introducer Kit. Ref Product No. AP-06014, Recall # Z-0285-2007;
q) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber
Catheter. Latex-Free A Port. 9 Fr. Introducer Kit Ref Product No. AP-06013,
Recall # Z-0286-2007;
r) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber
Catheter. Latex-Free A Port. Ref Product No. AP-01510, Recall # Z-0287-2007
CODE
a) Lot Numbers: MF2041118, MF2112625, MF3013201, MF3105944, MF4031465;
b) Lot Numbers: 11284, MF3085483, MF4031500, MF4063259;
c) Lot Numbers: MF3023376, MF3044179, MF3085273, MF3126313, MF4020636,
MF6014780, MF6025930, MF6079639, MR2070141;
d) Lot Numbers: 11750, 11999, 12059, MF4031397, MF4042081, MF4062934,
MF4063103, MF4073794, MF5027702, MF5059738, MF5060177, MF5060656,
MF5081903, MF5103211, MF6036473, MF6036909, MF6068938, MS3100148;
e) Lot Number: 12054, MF3033635, MF3075166, MF3095536, MF3105900, MF3116038,
MF4016607, MF4020455, MF4020838, MF4063175, MF4073793, MF4084293,
MF4084406, MF4105408, MF5017415, MF5049326, MF6014778, MF6068936,
MF6079334;
f) Lot Number: MF1033516, MF2071649, MF2081937, MF2082002, MF2092208,
MF2092278, MF2102373, MF2102462, MF2112595, MF2112688, MF2122960,
MF3013060, MF3013065, MF3013198, MF3013279, MF3013308, MF3023367,
MF3023427, MF3033567, MF3033642, MF3033732, MF3043847, MF3043910,
MF3044134, MF3054228, MF3054338, MF3054447, MF3054465, MF3064645,
MF3064763, MF3064833, MF3074927, MF3075118, MF3085281, MF3095491,
MF3095574, MF3095611, MF3105931, MF3106006, MF3116245, MF3126277,
MF3126278, MF3126318, MF3126396, MF3126417, MF3126450, MF4016582,
MF4016635, MF4020551, MF4020553, MF4020806, MF4031020, MF4031582,
MF4041771, MF4041936, MF4052333, MF4063058, MF4073792, MF4083964,
MF4084041, MF4084292, MF4094582, MF4094706, MF4105124, MF4105261,
MF4105486, MF4105803, MF4116118, MF5017414, MF5017549, MF5027701,
MF5028033, MF5028158, MF5038602, MF5050176, MF5059737, MF5060355,
MF5060468, MF5071341, MF5081670, MF5081671, MF5081762, MF5081870,
MF5081902, MF5082122, MF5082249, MF5092841, MF5093006, MF5103341,
MF5103508, MF5113683, MF5113875, MF5114153, MF5124319, MF5124528,
MF6014777, MF6025871, MF6026069, MF6026200, MF6036711, MF6057765,
MF6058113, MF6058190, MF6058298, MF6068660, MF6079304, MF6089737,
MF6089985, MS3110155, MS3110156, MS3110157, MS3110158, MS4031056,
MS4031058, MS4031059, MS4031065;
g) Lot Number: MF2102346, MF2112623, MF2122946, MF3023531, MF3043934,
MF3074943, MF3085287, MF3095692, MF4020550, MF4031019, MF4031353,
MF4041638, MF4063174, MF4105485, MF5017413, MF5017546, MF5038769;
h) Lot Numbers: 11916, MF2092169, MF2092256, MF3013079, MF3013159,
MF3013315, MF3013320, MF3023358, MF3033614, MF3043940, MF3064659,
MF3054234, MF3075086, MF3075140, MF3116147, MF3126395, MF4016579,
MF4031049, MF4031484, MF4063059, MF4063266, MF4105260, MF4105483,
MF4115980, MF4126889, MF4126890, MF5027945, MF5059894, MF5060175,
MF5092679, MF5103210, MF5113791, MF5124527, MF6015496, MF6025735,
MF6026194, MF6057764, MF6080022, MR3110192, MR3110194, MS2100122,
MS4041843, MS4041844, MS4041845;
i) Lot Numbers: MF2082014, MF2092092, MF2102287, MF2122972, MF3023424,
MF3033561, MF3033608, MF3054587, MF3074949, MF3075147, MF3085288,
MF3085340, MF3095656, MF3095740, MF3105983, MF3126394, MF4016539,
MF4031048, MF4031211, MF4031352, MF4041932, MF4062931, MF4063056,
MF4083962, MF4084405, MF4126532, MF5017410, MF5038601, MF5050044,
MF5059734, MF5081723, MF5124399, MF6015389, MF6025738, MF6026066,
MF6047369, MF6047370, MF6025851, MF6057763;
j) Lot Numbers: MF2081824, MF2092267, MF3013206, MF3023468, MF3033568,
MF3043935, MF3054360, MF3054525, MF3126300, MF4016726, MF4031047,
MF4042099, MF4062964, MF4105288, MF4105802, MF4126773, MF5027944,
MF5038765, MF5070950, MF5124151, MF6014960, MF6036562, MF6047448,
MF6058105, MF6058348, MF6036931, MF6068655;
k) Lot Numbers: 12025, 12026, MF2082053, MF2092149, MF2102348, MF2112612,
MF2112798, MF2122887, MF3013239, MF3023441, MF3033609, MF3033767,
MF3043953, MF3054471, MF3054551, MF3064671, MF3064720, MF3074950,
MF3075080, MF3085227, MF3085410, MF3106022, MF3126356, MF3116146,
MF4020300, MF4020624, MF4031189, MF4041636, MF4041931, MF4052351,
MF4063054, MF4063107, MF4063265, MF4073781, MF4073838, MF4105285,
MF4105479, MF4105680, MF4126531, MF4126772, MF4126885, MF5017407,
MF5028155, MF5038764, MF5050041, MF5059731, MF5059893, MF5060649,
MF5081721, MF5082121, MF5092678. MF5103209, MF5103504, MF5113992,
MF5114145, MF5124303, MF6015495, MF6036710, MF6047367, MF6047368,
MF6057762, MF6058411, MF6068650, MS3110150, MS4041840;
l) Lot Numbers: MF1075363, MF2071759, MF2071795, MF2081849, MF2081900,
MF2122871, MF2122962, MF3013303, MF3023498, MF3033750, MF3054449,
MF3054482, MF3085186, MF3085246, MF3085395, MF3095548, MF3116233,
MF3116244, MF4020723, MF4020901, MF4031014, MF4031015, MF4031466,
MF4052331, MF4062929, MF4063264, MF4084283, MF4094580, MF4094705,
MF4105328, MF4105577, MF4115963, MF4126528, MF4126656, MF4126883,
MF4126884, MF5017406, MF5027697, MF5028032, MF5028154, MF5038599,
MF5050172, MF5059730, MF5059892, MF5060353, MF5060465, MF5070948,
MF5081719, MF5081720, MF5124397, MF5082119, MF5092548, MF5103503,
MF5103681, MF5113874, MF5124524, MF6014999, MF6047362, MF6047363,
MF6047523, MF6057740, MF6057761, MF6068649, MF6068928, MF6079295,
MF6079297;
m) Lot Numbers: MF2071557, MF2081915, MF2112752, MF3013138, MF3013309,
MF3043927, MF3054236, MF3054472, MF3054594, MF3074941, MF3075061,
MF3085480, MF3095763, MF3116074, MF3116187, MF4016702, MF4016725,
MF4020805, MF4031013, MF4031188, MF4031373, MF4052203, MF4063052,
MF4073779, MF4073837, MF4094885, MF4105259, MF4105799, MF4126881,
MF5017404, MF5028031, MF5038301, MF5038425, MF5038760, MF5049322,
MF5059729, MF5059889, MF5060171, MF5081718, MF5103002, MF5103502,
MF5113789, MF5113991, MF6014861, MF6014998, MF6036561, MF6036618,
MF6058293, MF6058347, MF6068925;
n) Lot Numbers: MF2092160, MF2092258, MF4031012, MF4041798, MF4063372,
MF4073836, MF4105283, MF6015284, MF6026177;
o) Lot Number: 11953, 12024, 12048, MF2122834, MF2122873, MF3013094,
MF3023399, MF3033565, MF3033661, MF3043929, MF3044026, MF3044155,
MF3054297, MF3054407, MF3064741, MF3074954, MF3085360, MF3106021,
MF4016605, MF4020460, MF4031011, MF4031501, MF4041930, MF4062927,
MF4063051, MF4073944, MF4094579, MF4094883, MF4095027, MF4116113,
MF4126523, MF5017401, MF5049107, MF5049320, MF5059727, MF5060170
,MF5060348, MF5060463, MF5081716, MF5082118, MF5082247, MF5113788,
MF5113989, MF5124143, MF6014773, MF6025691, MF6036470, MF6036928,
MF6047447, MF6057759, MF6058188, MF6068647, MF6079327, MS3110160,
MS4073806;
p) Lot Numbers: 12130, 12134, MF3074955, MF3075069, MF3116186, MF3116232,
MF3126390, MF4020623, MF4073774, MF4094578, MF4094703, MF4126653,
MF5049105, MF5050037, MF5092675, MF5103680, MF6014995, MF6079156,
MF6089978;
q) Lot Numbers: MF2102345, MF2112624, MF2122835, MF3013200, MF3023408,
MF3023552, MF3033766, MF3054406, MF3074987, MF3075143, MF3095708,
MF3105784, MF3116130, MF3116231, MF4016530, MF4020444, MF4020470,
MF4041797, MF4062926, MF4073773, MF4084282, MF4094881, MF4116112,
MF4126522, MF4126770, MF4126879, MF5017542, MF5028152, MF5038758,
MF5049103, MF5059726, MF5060460, MF5081715, MF5082408, MF5092546,
MF5103679, MF5113983, MF6014772, MF6026163, MF6036927;
r) Lot Numbers: MF2061389, MF2071761, MF2082058, MF2122799,MF2122869,
MF3013124, MF3023533, MF3033713, MF3044092, MF3044143, MF3054233,
MF3054527,MF3064662, MF3064871, MF3085292, MF3085315, MF3095651,
MF3116183, MF3116212, MF3126476, MF4016721, MF4020469, MF4020739,
MF4105255, MF5017539, MF5081888, MF6068638, MS3110153,MS4041605,
MS4041616, MS4041617,MS4041618
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Reading, PA, by letter on September 29, 2006.
Manufacturer: Arrow International, Inc., Mount Holly, NJ. Firm initiated recall is ongoing.
REASON
Catheter has separated from the infusion port body.
VOLUME OF PRODUCT IN COMMERCE
10,594 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
OptiVantage DH Power Injection System, Recall # Z-0288-2007
CODE
All codes
RECALLING FIRM/MANUFACTURER
Mallinckrodt Inc., Cincinnati OH, by letter dated November 7, 2006. Firm initiated recall is ongoing.
REASON
The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinician, contrast would be injected at a higher or lower flow rate than desired.
VOLUME OF PRODUCT IN COMMERCE
1,348 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For use with the KaVo QUATTROcare maintenance unit only; Made in Germany The spray was produced under the following labels: a) KaVo QUTTROcare Spray AMERICA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany, single can: item #04117630, type 2106, 6-pack: item #04117640, type 2106A b) KaVo QUTTROcare Spray CANADA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany; Distributed by SciCan, 1440 Don Mills Rd, Toronto, Ontario, Canada M3B 3P9, single can: item #04117680, type 2107, 6-pack: item #04117690, type 2107A c) KaVo QUTTROcare Spray, Kaltenbach & Voigt GmbH, Postfach 1454, D-88396 Biberach/Riss Germany, single can: item #04117590, type 2108, 6-pack: item #04117720, type 2108A, Recall # Z-0289-2007
CODE
All cans manufactured prior to 11/18/06 Replacement product will have a new date/lot code on the bottom of the can which will end in R3X.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kavo America Corp, Lake Zurich IL, by letter, telephone and email on November 22, 2006.
Manufacturer: Kaltenbach & Voigt Gmbh & Co. KG, Biberach, Germany. Firm initiated recall is ongoing.
REASON
The QUATROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury.
VOLUME OF PRODUCT IN COMMERCE
619,434 cans
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. The dual program model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via DBS extension or DBS leads. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case. The operation of the neurostimulator is supported by a clinician programmer, a therapy controller, and a control magnet, Recall # Z-0290-2007
CODE
Serial numbers in the following ranges: • NFD100006 - NFD100325H • NFD620017S - NFD625737S • NFD200201K - NFD201303K
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neurological, Minneapolis, MN by letter dated July 2006.
Manufacturer: Medtronic Puerto Rico Operations Co., MedRel, Juncos, PR. Firm initiated recall is ongoing.
REASON
A subset of Kinetra implantable neurostimulators may experience a failure of wire connections between the electronic hybrid circuit and battery which may lead to sudden cessation of therapy. Sudden cessation of therapy can result in the immediate return or worsening of underlying symptoms due to the progression of the disease state.
VOLUME OF PRODUCT IN COMMERCE
6726 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finland +358 10 39411, Recall # Z-0291-2007
CODE
The lot number is always a six-digit number, where the first digits indicate the manufacturing sub-batch during the month and the last three digits indicate the month and year of the manufacture (MMY). The last three digits indicating month and year of manufacture are most significant. For example, a lot number ending in 086 indicates that this lot was manufactured in August 2006. -All lots manufactured in July, 2006 (076) or earlier are affected. -Compact Absorbers from lot numbers 133086 and 136086, manufactured in August, 2006, should be isolated and destroyed. All other lots manufactured in August 2006 (086) are acceptable for use. -All lots manufactured in September 2006 (096) or later are acceptable for use.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Datex - Ohmeda, Inc., Madison WI, by letter in September 2006
Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.
REASON
Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. The increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the pressure at the patient may be reduced. This could result in patient hypoventilation and hypoxia.
VOLUME OF PRODUCT IN COMMERCE
670,620 devices
DISTRIBUTION
Nationwide and Internationally
____________________________
PRODUCT
Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188, Recall # Z-0294-2007
CODE
Serial numbers 00010, 00011, 00012, 00013, 00014, 00015, 00016, 00017, 00019, 00020, 00024 through 00038, 00040, 00042 through 00050, 00052 through 00063, 00065 through 00082, 00084 through 00096, 00098 through 00103, 00105 through 00123, 00125 through 00152, 00154 through 00160, 00162 through 00174, 00176 through 00197, 00199 through 00208, 00211, 00213 through 00224 and 00226.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by on site visit between January 2004 and September 2005. Firm initiated recall is ongoing.
REASON
The flow meter could malfunction resulting in loss of touchscreen control of the gas system, but the alternate mechanical control will remain operable.
VOLUME OF PRODUCT IN COMMERCE
199 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
LIFEPAK 20 automatic external defibrillator, Recall # Z-0295-2007
CODE
Devices with software version -028, -030, -032, and -038.
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond WA, by letter dated December 2006 another in January 2007. Firm initiated recall is ongoing.
REASON
LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power.
VOLUME OF PRODUCT IN COMMERCE
10,307 devices
DISTRIBUTION
Nationwide and Internationally
____________________________
PRODUCT
a) St. Jude Medical APS III Programmer, used in combination with St. Jude Medical
bradycardia and tachycardia devices. Model 3500/3510, Recall # Z-0296-2007;
b) St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical
bradycardia and tachycardia devices. Model 3650, Recall # Z- 0297-2007;
c) St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR
Model 5376; Pulse Generators (pacemakers), Recall # Z-0298-2007
CODE
All Devices (all serial numbers for the devices referenced in the advisory.)
RECALLING FIRM/MANUFACTURER
St Jude Medical CRMD, Sylmar, CA, by letter on October 12, 2006, and by press release on October 13, 2006. Firm initiated recall is ongoing.
REASON
St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status.
VOLUME OF PRODUCT IN COMMERCE
229,411 device
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system features an ECG cable interface, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys (on/off, waveform/trend, alarm silence, menu/enter, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs, Recall # Z-0300-2007
CODE
Catalog Number 3404001, serial number ranges: AI05070075 - AI05070099, AI05090000 - AI05090024, AI05110040 - AI05110059, AI05120000 - AI05120010, AI05120013 - AI05120024, AI06010035 - AI06010049, AI06040000 - AI06040024, AI06060000 - AI06060014, AI06060016 - AI06060024, AI06070035 - AI06070041, AI06070043 - AI06070045. Catalog Number 3401001S, serial number range: AI05110000 - AI05110039
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha WI, by letter dated November 3, 2006. Firm initiated recall is ongoing.
REASON
An error occurred at the board manufacturing site which may affect the following parameters: - An electrical noise observed on the SpO2 pleth waveform generating and displaying erratic heart rates. % SpO2 reading displays dashes. The ECG waveform may appear noisy, ECG readings appear accurate. -Respiration waveform may appear noisy and the respiration readings will be displayed as dashes.
VOLUME OF PRODUCT IN COMMERCE
207 devices
DISTRIBUTION
Nationwide and Internationally
____________________________
PRODUCT
a) Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors.
Model numbers 4715319, 5206110, 5732388, and 7489375,
Recall # Z-0301-2007;
b) Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series
patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375,
Recall # Z-0302-2007;
c) Infinity Docking Station (IDS) (transportable patient monitor) Repair Kit,
part number 7262814, Recall # Z-0303-2007
CODE
All units installed or repaired prior to November 8, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, PA, The recalling firm issued a recall letter to the US customers November 17, 2006.
Manufacturer: Draeger Medical Systems Inc., Danvers, MA. Firm initiated recall is ongoing.
REASON
Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.
VOLUME OF PRODUCT IN COMMERCE
3556 units
DISTRIBUTION
Nationwide
____________________________
PRODUCT
4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System; All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-Varian Treatment versions 6.6.5027 and below, Recall # Z-0304-2007
CODE
All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-Varian Treatment versions 6.6.5027 and below, with Serial numbers H510946, H510651, H510190
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Inc., Palo Alto CA, by letter on September 21, 2006. Firm initiated recall is ongoing.
REASON
Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.
VOLUME OF PRODUCT IN COMMERCE
1,689 Units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________
PRODUCT
Feed 454A - Kalmbach 18% Turkey & Broiler Grower/Finisher Pellet (Medicated), Net Weight 50 LBS., Recall # V-009-2007
CODE
Lot: 004863
RECALLING FIRM/MANUFACTURER
Kalmbach Feeds Inc, Upper Sandusky OH, by telephone on November 29, 2006. Firm initiated recall is ongoing.
REASON
Off label use of Type A medicated article. Product is labeled for calves and used in poultry feed.
VOLUME OF PRODUCT IN COMMERCE
50/50 lb. bags
DISTRIBUTION
PA and MI

END OF ENFORCEMENT REPORT FOR DECEMBER 27, 2006

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