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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March 16, 2005
05-11

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
a) Melissa's Dried Papaya Strips, 3 oz. plastic bag.
Packed in 6/3 oz. packages per case or 12/3 oz.
packages per case. UPC code: 0 45255 11636.
Recall # F-200-5;
b) Rookies Snak Trail Mix, 8 oz. plastic bag.
Packed in 12/8 oz. packages per case.
UPC code: 0 45255 11263. Recall # F-201-5.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
World Variety Produce, Inc., Vernon, CA, by telephone and email, on February 4, 2005. Firm initiated recall is complete.
REASON
The product contains undeclared colors -- FD&C Yellow #5, Yellow #6, and Red #40.
VOLUME OF PRODUCT IN COMMERCE
335 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Alpha ATP Apple Flavor Drink, 20.3 Fl. oz.
plastic bottle, sold by the bottle or in 4
packs, or 12 per case. Recall # F-202-5;
b) Alpha ATP Pineapple Flavor Drink, 20.3 Fl. oz.
plastic bottle, sold by the bottle or in 4
packs, or 12 per case. Recall # F-204-5;
c) Alpha ATP Wild Raspberry Flavor Drink, 20.3 Fl. oz.
plastic bottle, sold by the bottle or in 4
packs, or 12 per case. Recall # F-205-5.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Muscle Marketing USA, Valencia, CA, by letters beginning on September 23, 2002. Firm initiated recall is complete.
REASON
a) The product contains undeclared color --
FD&C Blue #1 and FD&C yellow #5;
b) The product contains undeclared color --
FD&C Yellow #5;
c) The product contains undeclared color --
FD&C yellow #5, FD&C Blue #1, and FD&C Ted #40.
VOLUME OF PRODUCT IN COMMERCE
2,000 cases.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Up Your Gas Energy Booster, Dietary Supplement Caplets. 60 tablets per bottle. Ingredients include extracts of ginseng, guarana seed, kola nut, yerba mate leaf and niacin. Recall # F-206-5.
CODE
Lot # 109810804, EXP Date 08/07.
RECALLING FIRM/MANUFACTURER
Nutrition Formulators, Inc., Miami Lakes, FL, by letter on December 1, 2004. Firm initiated recall is ongoing.
REASON
The product contains pesticide contaminants.
VOLUME OF PRODUCT IN COMMERCE
3,480 bottles of 60 each tablets.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Acme Spaghetti Traditional Sauce, 26 oz. jar. The product is shipped in cases containing 12 jars. Recall # F-208-5.
CODE
Best if Used by 10/23/06.
RECALLING FIRM/MANUFACTURER
Albertsons, Inc., Boise, IA, by telephone and e-mail on February 16, 2 005. Firm initiated recall is complete.
REASON
Product is contaminated with glass-like foreign objects.
VOLUME OF PRODUCT IN COMMERCE
21,252 jars.
DISTRIBUTION
PA, NJ, MD, and DE.

_______________________________
PRODUCT
a) Golden Farm Candies brand sugar free Chocolate
Mint Nougat Swirls in 3.25 oz. cello packages
and 25 pound boxes. Recall # F-209-5;
b) Golden Farm Candies brand sugar free Assorted
Nougat Swirls in 3.25 oz. cello packages and
25 pound boxes. Recall # F-210-5.
CODE
All lots/units.
RECALLING FIRM/MANUFACTURER
Fudge Farms, Inc., South Bend, IN, by letters dated January 16, 2005. Firm initiated recall is ongoing.
REASON
The product contains the undeclared colors -- FD&C Yellow # 5 and FD&C Blue #1.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide and Australia.

_______________________________
PRODUCT
Meriita Autum Grain Bread, 20 oz. package. UPC 1220004050. Red colored twist tie. Recall # F-211-5.
CODE
Production code -- FEB 28 45 047.
RECALLING FIRM/MANUFACTURER
Interstate Brands Corp. Hdqtrs., Kansas City, MO, by press release on February 22, 2005 and by store visits on February 23, 2005. Firm initiated recall is ongoing.
REASON
The product contains fragments of digital thermometer.
VOLUME OF PRODUCT IN COMMERCE
15,000 loaves.
DISTRIBUTION
FL, GA, and SC.

_______________________________
PRODUCT
Euro Pipo Jelly PIPO brand variety flavored jelly desert, 705 g. Product of Thailand. Recall # F-212-5.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Food King, Inc., West Haven, CT, by letter dated November 30, 2004. Firm initiated recall is complete.
REASON
Product contains undeclared nonpermitted color ponceau 4R and undeclared colors tartrazine (certifiable as FD&C Yellow No. 5), sunset yellow FCF (certifiable as FD&C Yellow No. 6) and brilliant blue FCF (certifiable as FD&C Blue No. 1) based on New York State Department of Agriculture and Markets' analysis.
VOLUME OF PRODUCT IN COMMERCE
170 cases.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Alpha ATP Wild Cherry Flavor Drink, 20.3 Fl. oz. plastic bottle, sold by the bottle or in 4 packs, or 12 per case. Recall # F-203-5.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Muscle Marketing USA, Valencia, CA, by letters beginning on September 23, 2002. Firm initiated recall is complete.
REASON
The product contains undeclared color -- FD&C Red #40.
VOLUME OF PRODUCT IN COMMERCE
2,000 cases.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
2% milk sold in 1 gallon plastic jugs under the following labels: Crowley; Price Chopper; Always Save; Hannaford; Save-A-Lot; Nice N'Easy. Recall # F-207-5.
CODE
JAN 19 36 1376.
RECALLING FIRM/MANUFACTURER
H. P. Hood, Inc., Chelsea, MA, by telephone, visits and letters on January 4, and January 5, 2005. Firm initiated recall is complete.
REASON
The product may contain added sucrose due to a manufacturing error at the plant.
VOLUME OF PRODUCT IN COMMERCE
10,300/1-gallon containers.
DISTRIBUTION
NY, CT, MA, NH, RI, and VT.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

______________________________
PRODUCT
a) Nefazodone HC1 Tablets, 50 mg, 100 count blister
packs, Rx only. Recall # D-125-5;
b) Nefazodone HC1 Tablets, 100 mg, 100 count blister
packs, Rx only. Recall # D-126-5;
c) Nefazodone HC1 Tablets, 150 mg, 100 count blister
packs, Rx only. Recall # D-127-5;
d) Nefazodone HC1 Tablets, 200 mg, 100 count blister
packs, Rx only. Recall # D-128-5.
CODE
a) Lot 118557A, Exp. Date 6/2005;
b) Lot 118550, Exp. Date 7/2005;
c) Lot 118552, Exp. Date 6/2005;
d) Lot 118555, Exp. Date 7/2005;
RECALLING FIRM/MANUFACTURER
Ivax Pharmaceuticals, Inc., Northvale, NJ, by letters and telephone beginning on January 19, 2005. Firm initiated recall is ongoing.
REASON
Dissolution Failure: Lots may fail to meet requirements for dissolution throughout expiration.
VOLUME OF PRODUCT IN COMMERCE
50 mg-949 units; 100 mg 937 units; 150 mg-1348 units, 200 mg-1316 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Source Plasma. Recall # B-0705-5.
CODE
Unit numbers: 93438100, 93439374.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Kennewick, WA, by facsimile on March 14, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had elevated alanine aminotransferase (ALT) levels, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CO.

_______________________________
PRODUCT
Source Plasma. Recall # B-0734-5.
CODE
BWSVDL, BWSTQX, BWQTHP, BWQSVT, BWQSKZ, BWQRZP, BWQRPL, BWPVCL, BWPTYF, BWPTMC, BWPSYZ, BWPSMP, BWPSCK, BWPRRJ, BWPRDD, BWMBJW, BWLZWJ, BWLZLK, BWLYYV, BWLYQC, BWLYDR, BWMNGO, BWMMVS, BWMLSB, BWMLGK, BWMKXT, BWMKNC, BWMKDP, BWMJRX, BWMJHQ, BWMHVZ, BWMHMY, BWMGSQ, BWMFRY, BWMFJJ, BWKBTZ, BWKBLY, BWJZWM, BWJZJQ, BWJVYC, BWJJDB, BWJHQF, BWJDTQ, BWJDFM, BWJGPT, BWJGBR, BWJFLF, BWJCRT, BWJCBT, BWJBLV, BWHZWY, BWHZGN, BWHYNS.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Inc., Tulsa, OK., by fax dated November 5, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who failed to disclose a previous positive test for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
53 units.
DISTRIBUTION
IL, and Germany.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0736-5.
CODE
Unit FW29535.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on June 16, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to Platelets that were contaminated with gram positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Human Corneas for Transplantation. Recall # B-0739-5.
CODE
2005-0092 (CNOS) & 2005-0092 (CNOD).
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of Oregon, Portland, OR, by telephone on Juanuary 26, 2005, and by letter dated January 26, 2005. Firm initiated recall is complete.
REASON
Human tissue, procured from a donor who may have participated in high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas.
DISTRIBUTION
NY, and CA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0741-5.
CODE
Units 2626591 (Parts A & B).
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on December 30, 2004.
Manufacturing Firm: LifeSource Oak Lawn, Oak Lawn, IL. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with gram-positive cocci, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0742-5.
CODE
Unit 22GW96812.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on May 31, 2004. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding Platelets were contaminated with Staphylococcus warneri, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0743-5;
b) Fresh Frozen Plasma. Recall # B-0744-5.
CODE
a) and b) Unit 22FS26179.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on August 9, 2004 and by letter dated August 10, 2004. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding Platelets were contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ and PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0745-5.
CODE
Unit 22FX07951.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on August 27, 2004 and by letter dated August 27, 2004. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding Platelets were contaminated with Staphylococcus capitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0747-5;
b) Recovered Plasma. Recall # B-0748-5.
CODE
a) and b) Unit 8364545.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile and letter on August 19, 2003. 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
LA, and Switzerland.

_______________________________
PRODUCT
RAPID HIV Test Kits. Recall # B-0749-5.
CODE
Test Kits.
RECALLING FIRM/MANUFACTURER
UPS Supply Chain Solutions, d.b.a. FDTS, Alpharetta, GA, by letter, dated February 4, 2005. Firm initiated recall is complete.
REASON
Unapproved, HIV diagnostic test kits, were distributed.
VOLUME OF PRODUCT IN COMMERCE
646 Kits.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Source Plasma. Recall # B-0750-5.
CODE
Unit F30508143.
RECALLING FIRM/MANUFACTURER
Advanced BioServices, LLC (formerly known as Tri-Cities Plasma Corp.), Johnson City, TN, by facsimile on August 28, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0751-5.
CODE
Units 8959312, 8959320.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on November 10, 2003 and by letter dated November 25, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA, and MI.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0752-5;
b) Red Blood Cells, Leukocytes Reduced.
Recall # B-0753-5;
c) Platelets. Recall # B-0754-5.
CODE
a) Units 6951562, 6876348;
b) Units 8370498, 8519910, 8316891;
c) Units 8316891, 6951562, 8519910.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on November 19, 2003 and by letter dated December 5, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
LA, and MI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0755-5.
CODE
Units 8958312, 9554788.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on November 5, 2003 and by letter dated November 14, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0756-5.
CODE
Unit 8951230.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on September 29, 2003 and by letter dated October 7, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0757-5.
CODE
Units 7219970 (split unit).
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone and facsimile beginning May 11, 2004. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Cryoprecipitated AHF, Pooled. Recall # B-0758-5.
CODE
Unit numbers: 10732, 10747, 10750, 10751, 10799, 10805, 10811, 10816, 10847, 10849, 10853, 10858, 10864, 10865, 10866, 10868, 10869, 10875, 10879, 10933, 10938, 10939, 10940, 10943, 10950, 10952, 10956, 10959, 10982, 11029, 10736, 10737, 10753, 10756, 10757, 10758, 10759, 10768, 10772, 10774, 10787, 10804, 10807, 10843, 10871, 10878, 10909, 10911, 10912, 10915, 10917, 10920, 10924, 10945, 10948, 10953, 10954, 10957, 10964, 10969, 10970, 11011, 11012, 11016, 11022, 11055, 10741, 10742, 10766, 10771, 10776, 10777, 10778, 10779, 10780, 10781, 10798, 10801, 10803, 10813, 10814, 10815, 10817, 10820, 10821, 10823, 10824, 10825, 10826, 10828, 10829, 10830, 10831, 10832, 10833, 10834, 10835, 10836, 10838, 10840, 10842, 10860, 10862, 10863, 10867, 10870, 10872, 10876, 10880, 10881, 10883, 10886, 10888, 10890, 10892, 10893, 10894, 10895, 10896, 10897, 10898, 10899, 10900, 10901, 10902, 10903, 10907, 10908, 10914, 10916, 10918, 10919, 10921, 10922, 10923, 10926, 10927, 10928, 10929, 10931, 10934, 10936, 10937, 10941, 10944, 10946, 10947, 10949, 10951, 10955, 10958, 10965, 10967, 10983, 10984, 10987, 10988, 10989, 10990, 10992, 10993, 11013, 11018, 11023, 11024, 11025, 11026, 11027, 11030, 11031, 11032, 11034, 11075, 11078, 11080, 11081, 11101, 11105, 11109, 11112, 11113, 11114, 10752, 10754, 10755, 10760, 10763, 10765, 10770, 10789, 10791, 10792, 10793, 10794, 10795, 10796, 10932, 10935, 10942, 10783, 11047, 11048, 10806, 10819, 10845, 10857, 10861, 10734, 10735, 10746, 10748, 10786, 10788, 10802, 10852, 10854, 10855, 10856, 10877, 10904, 10905, 10906, 10910, 10913, 10930, 10960, 10968, 10972, 10975, 10976, 10977, 10978, 10979, 10980, 11045, 11049, 10764, 10767, 10773, 10809, 10844, 10846, 10873, 10874, 10738, 10739, 10744, 10859, 10882, 10887, 10889, 10885, 10782, 10808, 10812.
RECALLING FIRM/MANUFACTURER
American Red Cross, Pacific Northwest Region, Portland, OR, by telephone on October 17, 2003 and by letter dated, October 31, 2003. Firm initiated recall is complete.
REASON
Pooled Cryoprecipitate, that failed to meet the minimum specifications for fibrinogen levels, was distributed.
VOLUME OF PRODUCT IN COMMERCE
255 units.
DISTRIBUTION
OR.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0759-5.
CODE
Units 8954566, 9554612, 9554618.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on November 10, 2003 and by letter dated November 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0760-5.
CODE
Unit 7220276.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on June 18, 2004, and by facsimile dated September 28, 2004. Firm initiated recall is complete.
REASON
Platelets, labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0761-5;
b) Recovered Plasma. Recall # B-0762-5.
CODE
a) and b) Unit 8707243.
RECALLING FIRM/MANUFACTURER
Our Lady of Lourdes Regional Medical Blood Center, Lafayette, LA, by facsimile on June 24, 2003 and by letter dated June 24, 2003. 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
FL, and LA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0763-5;
CODE
Unit 53FE88833.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD, by letter dated September 9, 2004. Firm initiated recall is complete.
REASON
Red Cells, collected from a donor taking the medication, Tazorac, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
Recall # B-0769-5;
b) Recovered Plasma. Recall # B-0770-5.
CODE
a) and b) Units FG52314, FK35887.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., Providence, RI, by letter dated June 11, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
RI and Switzerland.
___________________________
PRODUCT
Recovered Plasma. Recall # B-0771-5.
CODE
Unit 8519274.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on June 23, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0772-5;
b) Red Blood Cells, Leukocytes Reduced.
Recall # B-0773-5;
c) Plasma Frozen. Recall # B-0774-5;
d) Cryoprecipitated AHF. Recall # B-0775-5;
e) Cryoprecipitated AHF, Pooled.
Recall # B-0776-5;
f) Recovered Plasma. Recall # B-0777-5.
CODE
a) Unit numbers: 21V68362, 21KS02102, 21V65396,
21GE11865, 21V57493, 21KF03262, 21V51637, and
21V49872;
b) and c) Unit number: 21GE14710;
d) Unit numbers: 21KF03262, 21V51637, and 21V49872;
e) Unit numbers: 21V65396, 21V57493;
f) Unit numbers: 21V68362, 21KS02102, 21V65396,
21GE11865, 21V57493, and 21V47653.
RECALLING FIRM/MANUFACTURER
American Red Cross, Pacific Northwest Region, Portland, OR, by letters, dated December 20, 2000, telephone on December 6, 2000, and by facsimile on December 11, 2000. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking the medication, Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
OR, CA, UT, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0778-5;
b) Recovered Plasma. Recall # B-0779-5.
CODE
a) and b) Unit 8512575.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA
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
LA, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0780-5;
b) Red Blood Cells, Leukocytes Reduced.
Recall # B-0781-5;
c) Red Blood Cells, Leukocytes Reduced,
Irradiated. Recall # B-0782-5;
d) Cryoprecipitated AHF. Recall # B-0783-5;
e) Recovered Plasma. Recall # B-0784-5;
f) Platelets for Manufacturing Use Only.
Recall # B-0785-5.
CODE
a) Unit 9556213;
b) Units 8955012, 8529765;
c) Unit 8370918;
d) and e) Unit 8529765;
f) Unit 8370918.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone, facsimile, and letter beginning September 30, 2003. 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
7 units.
DISTRIBUTION
LA, NY, PA, and Switzerland.

_______________________________
PRODUCT
a) Whole Blood, Leukocytes Removed.
Recall # B-0786-5;
b) Red Blood Cells. Recall # B-0787-5;
c) Red Blood Cells, Leukocytes Reduced.
Recall # B-0788-5;
d) Platelets. Recall # B-0789-5;
e) Platelets, Irradiated. Recall # B-0790-5;
f) Platelets Pheresis. Recall # B-0791-5;
g) Platelets Pheresis, Irradiated. Recall # B-0792-5;
h) Fresh Frozen Plasma. Recall # B-0793-5;
i) Fresh Frozen Plasma (Apheresis). Recall # B-0794-5;
j) Plasma Frozen. Recall # B-0795-5;
k) Plasma. Recall # B-0796-5;
l) Cryoprecipitated AHF. Recall # B-0797-5;
CODE
a) Unit number: 32LL71985;
b) Unit numbers: 32KH98711 32GL60331 32FC29398
32FC29416 32FC29421 32KQ27019 32KF64705 32KQ27504
32KQ27750 32KF65086 32KH99893 32KF65365 32KF65379
32KE00090 32KE00131 32KE00134 32KE00136 32KE00138
32KE00141 32KE00142 32KE00148 32FE62748 32KE00153
32KF65348 32KQ28624 32GL61028 32FE64102 32KL03082
32FC29400 32LL72406 32LL72414 32LL72421 32KQ28739
32FE64087;
c) Unit numbers: 32FE62739 32FE62756 32FE62725 32KQ27783
32KQ27786 32KQ27804 32FC29636 32KH99715 32KL02927
32KQ28978;
d) Unit numbers: 32KM15951 32LL71168 32GL60297 32GL60314
32GL60315 32GL60317 32GR01393 32KH98870 32GL60412
32KF64664 32KQ27325 32KH99075 32KF64698 32KF64705
32KF64755 32KH99219 32KQ27504 32KQ27538 32KQ27635
32KQ27678 32KQ27751 32KQ27772 32KQ27856 32KQ27871
32KF65102 32KH99715 32KJ56331 32KJ56339 32GR02454
32KH99854 32KH99900 32KH99907 32KF65268 32KF65283
32KF65298 32KF65318 32KJ56580 32KJ56594 32KJ56602
32KF65351 32KF65353 32KF65354 32KF65356 32KF65358
32KF65359 32KF65360 32KF65361 32KF65363 32KF65365
32KF65367 32KF65369 32KF65371 32KF65372 32KF65375
32KF65377 32KF65379 32KF65380 32KM16241 32KM16242
32KM16243 32KM16244 32KM16245 32KM16246 32KM16248
32KM16249 32KM16250 32KM16252 32KM16253 32KM16254
32KM16255 32KM16256 32KM16261 32KE00082 32KE00084
32KE00085 32KE00086 32KE00087 32KE00088 32KE00089
32KE00090 32KE00091 32KE00092 32KE00093 32KE00095
32KE00096 32KE00097 32KE00098 32KE00099 32KE00100
32KE00101 32KE00102 32KE00103 32KE00104 32KE00105
32KE00106 32KE00107 32KE00108 32KE00109 32KE00112
32KE00113 32KE00114 32KE00116 32KE00117 32KE00118
32KE00119 32KE00120 32KE00121 32KE00122 32KE00123
32KE00125 32KE00127 32KE00130 32KE00131 32KE00132
32KE00133 32KE00134 32KE00135 32KE00136 32KE00137
32KE00138 32KE00139 32KE00142 32KE00143 32KE00144
32KE00146 32KE00147 32KE00293 32KJ56752 32GR03130
32KJ56807 32KJ56829 32KE00380 32GL61103 32KQ28964
32KQ28971 32KF65579 32KF65595 32KJ56941 32KF65637
32KQ29064 32KQ29078 32KH98718 32KH98732 32KQ27518
32KQ27555 32KQ27542 32KF65373 32KF65374 32KM16259
32KM16260 32KM16263 32KE00081 32KE00110 32KE00111
32KE00128 32KE00129 32KF65430 32KQ28846 32KL03067
32KQ28942 32KQ28949 32KE00148 32KE00149 32KE00151
32KE00152 32KE00153 32KF65342 32KF65343 32KF65344
32KF65346 32KF65347 32KF65349 32KF65350 32KJ56617
32KF65416 32KF65424 32GE25792 32KQ28693 32GR02891
32GE25785 32KF65445 32KQ28686 32KE00277;
e) Unit numbers: 32KF65355 32KM16247 32KM16251
32KE00083 32KE00140 32KE00141 32KJ56856 32KF65572;
f) Unit numbers: 32KP11703 32FP05782 (Parts 1 & 2)
32FP05783 32FP05784 (Parts 1 & 2) 32FP05786 (Parts 1
& 2) 32FP05787 (Parts 1 & 2) 32FP05788 (Parts 1 & 2)
32FP05789 32KP11714 32KP11715 (Parts 1 & 2) 32KP11716
(Parts 1 & 2) 32KP11720 32FP05797 (Parts 1 & 2)
32GP09833 32KP11755 32GP09925 32GP09948 (Parts 1 & 2)
32KP11938 (Parts 1 & 2) 32FP05866 (Parts 1 & 2)
32GP09956 (Parts 1 & 2) 32GP09978 (Parts 1 & 2)
32KP12003 32GP09996 32KP12010 32KP12017 (Parts 1 & 2)
32KP12029 32FP05893 (Parts 1 & 2) 32KP12049 (Parts 1 &
2) 32KP12038;
g) Unit numbers: 32FP05785;
h) Unit numbers: 32KM15951 32LL71168 32GF34390
32GL60412 32KL02802 32GM05192 32KJ56135 32KF65086
32KF65102 32KH99715 32KJ56323 32KJ56339 32KQ28191
32GR02734 32KH99878 32KH99900 32KF65232 32KF65268
32KF65318 32KJ56580 32KJ56602 32KF65354 32KF65355
32KF65356 32KF65358 32KF65362 32KF65365 32KF65367
32KF65372 32KF65379 32KF65380 32KM16241 32KM16245
32KM16246 32KM16247 32KM16250 32KM16251 32KM16252
32KM16256 32KE00092 32KE00101 32KE00102 32KE00104
32KE00107 32KE00117 32KE00122 32KE00131 32KE00133
32KE00134 32KE00136 32GL60394 32KE00138 32KE00140
32KE00142 32KE00144 32KE00148 32KF65342 32KF65343
32KF65350 32GR02891 32KF65416 32KF65424 32GE25792
32GR03071 32KC05524 32KQ28693 32KE00293 32KE00350
32KE00358 32GR03130 32KJ56807 32KE00380 32KQ28861
32GF34960 32GL61111 32KJ56856 32KQ28964 32KQ28971
32KF65637 32KQ29064 32KQ29078 32KH98718 32KF65373
32KE00111 32KL03067;
i) Unit numbers: 32FP05785 32FP05789 32GP09874;
j) Unit numbers: 32FE62745 32FE64118 32FE64146
32FE64188;
k) Unit numbers: 32LL72007 32KJ56800 32KJ56849;
l) Unit numbers: 32GL60318 32GL60319 32GL60320
32GL60321 32GL60322 32GL60323 32GL60324 32GL60325
32GL60326 32GL60327 32GL60328 32GL60329 32GL60330
32GL60331 32GL60332 32GL60333 32GL60334 32GL60336
32GL60337 32GL60338 32GL60339 32GL60340 32GL60341
32GL60342 32GL60343 32GL60344 32GL60345 32GL60346
32GL60347 32GL60348 32GL60349 32GL60350 32GR01423
32KQ27182 32KJ56116 32LL72007 32GE25615 32GE25732
32GE25755 32KJ56673 2KJ56687 32KJ56726 32KQ28624
32KQ28646 32GE25814 32KQ28709 32KQ28716 32KE00300
32KQ28739 32KQ28753 32KQ28768 32KQ28790 32KQ28797
32KQ28820 32GR03145 32KJ56800 32KJ56849 32KQ2754.1.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross, Madison, WI, by letter, dated October 14, 1999.
Manufacturing Firm: American Red Cross, National Testing Laboratory, Eagan, MN. Firm initiated recall is ongoing.
REASON
Blood products, incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
435 units.
DISTRIBUTION
IL, WI, CA, IA, SC, PA, GA, MI, and OH.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0798-5.
CODE
Unit 7219904.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on May 17, 2004. Firm initiated recall is complete.
REASON
Blood product, which had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0809-5;
b) Recovered Plasma. Recall # B-0810-5.
CODE
a) and b) Unit number: 21Q97038.
RECALLING FIRM/MANUFACTURER
American Red Cross, Pacific Northwest Region, Portland, OR, by facsimile on December 28, 2000, and by letter, dated January 4, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0819-5.
CODE
Unit numbers: 22KX66872, 22KX66882, 22KX66894, 22KX66918, and 22KX66876.
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on July 14, and 30, 2004, by facsimile on July 30, 2004, and by letter dated August 5, 2004. Firm initiated recall is complete.
REASON
Blood products, collected using a hematocrit centrifuge that did not have quality control performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
NJ, and PA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0740-5.
CODE
Unit 22LJ86111.
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn-Jersey Region, Philadelphia, PA, by facsimile dated June 17, 2004. Firm initiated recall is complete.
REASON
Red Blood Cells, mislabeled for the M antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0746-5.
CODE
Unit 8375394.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on January 7, 2003. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced, but had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0815-5.
CODE
Unit numbers: 9008244, 9008281, 9008342, 9008435, 9008172, 9008187, 9008398, 9008376, 9008476, 9008450, 9008447, and 9008475.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by facsimile on August 25, 2003. Firm initiated recall is complete.
REASON
Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
AK, and ID.

_______________________________
PRODUCT
Source Plasma. Recall # B-0816-5.
CODE
Unit number: XR38557.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Fargo, ND, by facsimile on August 15, 1997. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history was not determined at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0818-5.
CODE
Unit number: 6704020.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc, Anchorage, AK, by telephone on May 21, 2003. Firm initiated recall is complete.
REASON
Blood product, that did not have the complete amount of additive solution included, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AK.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed, Irradiated. Recall # B-0820-5.
CODE
Unit number: LN93024.
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Jackson, TN, by telephone on August 13, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
LIFEPAK 500 AED. Recall # Z-0562-05.
CODE
Serial numbers - various, noncontiguous Part numbers - 3005400-XXX, D3005400-XXX, U3005400-XXX.
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter on February 3, 2005 and by telephone and letter beginning on March 1, 2005. Firm initiated recall is ongoing.
REASON
Potential to not detect patients at the low end of the patient impedance range.
VOLUME OF PRODUCT IN COMMERCE
1,953 devices.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Medline Custom Sterile Surgical Packs which contain a Tyvek Breather Pouch, part number 32901, the breather pouch measures 25.25 inches x 30.75 inches, 5 mil thick. Recall # Z-0554-05.
CODE
Lot numbers 44134-01 and 43589-01; all lots distributed between 6/15/04 and 3/1/05 of the following reorder numbers: DYNJ02170A, DYNJ02176A, DYNJ02179B, DYNJ02182A, DYNJ04314A, DYNJ04316, DYNJ04321, DYNJ04325, DYNJ04329, DYNJ04336B, DYNJ04338B, DYNJ04371, DYNJ04383, DYNJ04388, DYNJ04407A, DYNJ04408A, DYNJ04419A, DYNJ04427, DYNJ04455, DYNJ04468B, DYNJ04472A, DYNJ04476, DYNJ04478A, DYNJ04481B, DYNJ04482, DYNJ04483, DYNJ04485, DYNJ04494, DYNJ04497, DYNJ04502, DYNJ04504, DYNJ04505, DYNJ04509, DYNJ04542, DYNJ04545, DYNJ04548A, DYNJ04556A, DYNJ04557B, DYNJ04558A, DYNJ04572, DYNJ04579A, DYNJ04597, DYNJ04609, DYNJ04611A, DYNJ04620A, DYNJ04629B, DYNJ04676A, DYNJ04677, DYNJ04683, DYNJ04691, DYNJ04709A, DYNJ04710, DYNJ04711, DYNJ04711A, DYNJ04712, DYNJ04713A, DYNJ04720A, DYNJ04723, DYNJ04729, DYNJ04744, DYNJ04745A, DYNJ04754A, DYNJ04805A, DYNJ04807A, DYNJ04811, DYNJ04822A, DYNJ04825A, DYNJ04832, DYNJ04834, DYNJ04840, DYNJ04841, DYNJ04878, DYNJ04880, DYNJ04888, DYNJ05787K, DYNJ05798K, DYNJ06075G, DYNJ06324L, DYNJ06682B, DYNJ06739B, DYNJ06743A, DYNJ06744B, DYNJ06782A, DYNJ06796J, DYNJ06839A, DYNJ06873A, DYNJ06876D, DYNJ06876F, DYNJ06908B, DYNJ06927A, DYNJ06930F, DYNJ06952F, DYNJ06976, DYNJ07536, DYNJ07537C, DYNJ07626A, DYNJ07626A, DYNJ07626A, DYNJ07670C, DYNJ07833F, DYNJ07881C, DYNJ07910A, DYNJ07942, DYNJ07942, DYNJ07951A, DYNJ07954A, DYNJ07954A, DYNJ07982A, DYNJ07995, DYNJ08351K, DYNJ08387F, DYNJ08601A, DYNJ08671I, DYNJ08713C, DYNJ08796D, DYNJ08802, DYNJ08814F, DYNJ08815D, DYNJ08816C, DYNJ08840J, DYNJ08844I, DYNJ09066C, DYNJ09156F, DYNJ09174D, DYNJ09188A, DYNJ09194F, DYNJ09258R, DYNJ09259I, DYNJ09261J, DYNJ09294B, DYNJ09322D, DYNJ09343F, DYNJ09346, DYNJ09397A, DYNJ09398, DYNJ09449C, DYNJ09515C, DYNJ09528D, DYNJ09531D, DYNJ09532F, DYNJ09533F, DYNJ09590D, DYNJ09617B, DYNJ09619D, DYNJ09624A, DYNJ09677A, DYNJ09677C, DYNJ09681C, DYNJ09682B, DYNJ09684B, DYNJ09694A, DYNJ09703B, DYNJ09787B, DYNJ09807K, DYNJ09857B, DYNJ09858A, DYNJ09874C, DYNJ09875G, DYNJ09882A, DYNJ09921, DYNJ09923, DYNJ09932B, DYNJ09933, DYNJ09941C, DYNJ09981A, DYNJ14000A, DYNJ14002, DYNJ14005A, DYNJ14006, DYNJ14008A, DYNJ14014, DYNJ14017A, DYNJ14018A, DYNJ14024, DYNJ14038, DYNJ14039, DYNJ14069A, DYNJ14078A, DYNJ14079, DYNJ14095A, DYNJ14096B, DYNJ14097, DYNJ14107, DYNJ14107, DYNJ14110, DYNJ14112A, DYNJ14114, DYNJ14119, DYNJ14127, DYNJ14130, DYNJ14134, DYNJ14137, DYNJ14147A, DYNJ14148A, DYNJ14149A, DYNJ14150A, DYNJ14156B, DYNJ14157B, DYNJ14170, DYNJ14187, DYNJ14218A, DYNJ14225A, DYNJ15062, DYNJ15332A, DYNJ15392D, DYNJ15393G, DYNJ15428F, DYNJ15455P, DYNJ15494A, DYNJ15504D, DYNJ15519A, DYNJ15615D, DYNJ15643L, DYNJ15660C, DYNJ15660D, DYNJ15668D, DYNJ15703A, DYNJ15751C, DYNJ15752, DYNJ15814I, DYNJ15903C, DYNJ15956B, DYNJ15980A, DYNJ16018F, DYNJ16025B, DYNJ16026B, DYNJ16065A, DYNJ16072D, DYNJ16076I, DYNJ16079B, DYNJ16082B, DYNJ16114F, DYNJ16127C, DYNJ16131B, DYNJ16206A, DYNJ16250C, DYNJ16263C, DYNJ16274B, DYNJ16280B, DYNJ16284, DYNJ16289B, DYNJ16327C, DYNJ16327D, DYNJ16342, DYNJ16346A, DYNJ16350C, DYNJ16376C, DYNJ16379B, DYNJ16381C, DYNJ16384, DYNJ16435, DYNJ16461C, DYNJ16510D, DYNJ16514B, DYNJ16518A, DYNJ16535A, DYNJ16536A, DYNJ16541B, DYNJ16567C, DYNJ16575, DYNJ16577, DYNJ16589, DYNJ16591, DYNJ16604, DYNJ16604A, DYNJ16623, DYNJ16625, DYNJ16644, DYNJ17003A, DYNJ17008, DYNJ17016A, DYNJ17018, DYNJ17020, DYNJ17042, DYNJ17044, DYNJ17045A, DYNJ17053, DYNJ17065, DYNJ17068, DYNJ17082, DYNJ19022D, DYNJ19023C, DYNJ19029A, DYNJ19051B, DYNJ19061D, DYNJ19069B, DYNJ19073B, DYNJ19081D, DYNJ19109A, DYNJ19121, DYNJ19138C, DYNJ19139A, DYNJ19146C, DYNJ19146D, DYNJ19154B, DYNJ19170B, DYNJ19199A, DYNJ19230D, DYNJ19233B, DYNJ19234B, DYNJ19235A, DYNJ19249B, DYNJ19251A, DYNJ19256B, DYNJ19257A, DYNJ19296C, DYNJ19329C, DYNJ19371, DYNJ19390B, DYNJ19395B, DYNJ19416B, DYNJ19418D, DYNJ19419A, DYNJ19419B, DYNJ19441D, DYNJ19451I, DYNJ19461B, DYNJ19468A, DYNJ19469, DYNJ19479A, DYNJ19483, DYNJ19500A, DYNJ19501B, DYNJ19509C, DYNJ19515, DYNJ19527D, DYNJ19529A, DYNJ19550A, DYNJ19551B, DYNJ19564A, DYNJ19589A, DYNJ19590A, DYNJ19603B, DYNJ19611B, DYNJ19612B, DYNJ19620A, DYNJ19637G, DYNJ19638F, DYNJ19646D, DYNJ19655A, DYNJ19657, DYNJ19674B, DYNJ19675D, DYNJ19679D, DYNJ19684A, DYNJ19686, DYNJ19694A, DYNJ19696A, DYNJ19697A, DYNJ19699A, DYNJ19709C, DYNJ19710B, DYNJ19724A, DYNJ19726A, DYNJ19729A, DYNJ19730B, DYNJ19738, DYNJ19771B, DYNJ19775A, DYNJ19777A, DYNJ19777A, DYNJ19787B, DYNJ19788A, DYNJ19789A, DYNJ19790B, DYNJ19791D, DYNJ19804B, DYNJ19813, DYNJ19814A, DYNJ19816A, DYNJ19830, DYNJ19833, DYNJ19842A, DYNJ19850B, DYNJ19853, DYNJ19880B, DYNJ19882B, DYNJ19885B, DYNJ19887B, DYNJ19888, DYNJ19900C, DYNJ19901D, DYNJ19907, DYNJ19910, DYNJ19918B, DYNJ19919B, DYNJ19923, DYNJ19929A, DYNJ19929B, DYNJ19933G, DYNJ19935F, DYNJ19938, DYNJ19944, DYNJ19949A, DYNJ19951B, DYNJ19953A, DYNJ19955A, DYNJ19960B, DYNJ19964B, DYNJ19981A, DYNJ19997F, DYNJ20004F, DYNJ20007C, DYNJ20010A, DYNJ20012A, DYNJ20013A, DYNJ20020A, DYNJ20021A, DYNJ20026A, DYNJ20027A, DYNJ20028A, DYNJ20029, DYNJ20030B, DYNJ20031, DYNJ20034, DYNJ20040A, DYNJ20053B, DYNJ20055A, DYNJ20079A, DYNJ20081A, DYNJ20084, DYNJ20104, DYNJ20106A, DYNJ20107, DYNJ20114C, DYNJ20115, DYNJ20117, DYNJ20124A, DYNJ20125, DYNJ20126A, DYNJ20127A, DYNJ20134B, DYNJ20135C, DYNJ20137A, DYNJ20138B, DYNJ20142A, DYNJ20151B, DYNJ20169, DYNJ20170, DYNJ20181, DYNJ20185, DYNJ20186, DYNJ20187A, DYNJ20198A, DYNJ20200, DYNJ20202A, DYNJ20208, DYNJ20211A, DYNJ20213A, DYNJ20214A, DYNJ20215A, DYNJ20216, DYNJ20218A, DYNJ20221A, DYNJ20230, DYNJ20232, DYNJ20248B, DYNJ20252, DYNJ20335A, DYNJ20354A, DYNJ20355B, DYNJ20397A, DYNJ20405, DYNJ20409, DYNJ20422, DYNJ20425B, DYNJ20433, DYNJ20440A, DYNJ20441, DYNJ20442, DYNJ20462B, DYNJ20463, DYNJ20465B, DYNJ20466A, DYNJ20468B, DYNJ20472B, DYNJ20485B, DYNJ20487B, DYNJ20488B, DYNJ20489, DYNJ20489B, DYNJ20490A, DYNJ20491B, DYNJ20495B, DYNJ20496A, DYNJ20498A, DYNJ20498B, DYNJ20502B, DYNJ20503A, DYNJ20507A, DYNJ20508A, DYNJ20509B, DYNJ20518C, DYNJ20521A, DYNJ20522, DYNJ20522A, DYNJ20540B, DYNJ20567B, DYNJ20567B, DYNJ20609A, DYNJ20609B, DYNJ20639A, DYNJ20643A, DYNJ20696A, DYNJ20738, DYNJ20767B, DYNJ20775B, DYNJ20788B, DYNJ20789B, DYNJ20792, DYNJ20792, DYNJ20794, DYNJ20797A, DYNJ20806A, DYNJ20810, DYNJ20829A, DYNJ20834, DYNJ20838A, DYNJ20844A, DYNJ20846A, DYNJ20870, DYNJ20872A, DYNJ20888A, DYNJ20890A, DYNJ20891A, DYNJ20899, DYNJ20910, DYNJ20911A, DYNJ20913, DYNJ20928B, DYNJ20932B, DYNJ20933A, DYNJ20942A, DYNJ20955, DYNJ20994, DYNJ21003, DYNJ21011B, DYNJ21016, DYNJ21018, DYNJ21019A, DYNJ21020B, DYNJ21030, DYNJ21049A, DYNJ21063A, DYNJ21073B, DYNJ21088C, DYNJ21096, DYNJ21097, DYNJ21100A, DYNJ21123, DYNJ21140, DYNJ21149, DYNJ21149A, DYNJ21175A, DYNJ21183, DYNJ21187A, DYNJ21190, DYNJ21191, DYNJ21193, DYNJ21226, DYNJ21249, DYNJ21265, DYNJ21294A, DYNJ21296A, DYNJ21304, DYNJ21307A, DYNJ21307B, DYNJ21320, DYNJ21322, DYNJ21324B, DYNJ21327A, DYNJ21328B, DYNJ21329A, DYNJ21378, DYNJ21399A, DYNJ21400, DYNJ21404B, DYNJ21405A, DYNJ21406A, DYNJ21425, DYNJ21451A, DYNJ21452, DYNJ21475, DYNJ21476, DYNJ21484, DYNJ21485, DYNJ21491, DYNJ21494, DYNJ21497, DYNJ21497A, DYNJ21511, DYNJ21513, DYNJ21526, DYNJ21527, DYNJ21529, DYNJ21530, DYNJ21540, DYNJ21545, DYNJ21557, DYNJ21562, DYNJ21567, DYNJ21569, DYNJ21584, DYNJ21601, DYNJ21633, DYNJ21635, DYNJ21635A, DYNJ21677, DYNJ21718, DYNJ21721, DYNJ21722, DYNJ21726, DYNJ21728, DYNJ21736, DYNJ21737, DYNJ21739, DYNJ21777A, DYNJ21785, DYNJ21792A, DYNJ21797, DYNJ21798, DYNJ21803, DYNJ21804, DYNJ21805, DYNJ21817, DYNJ21818, DYNJ21826, DYNJ21827, DYNJ21828, DYNJ21839, DYNJ21886, DYNJ21965, DYNJ25096D, DYNJ25104D, DYNJ25167B, DYNJ25222B, DYNJ25229C, DYNJ25235C, DYNJ25240A, DYNJ25243A, DYNJ25270C, DYNJ25421A, DYNJ25458, DYNJ25461A, DYNJ25468C, DYNJ25538A, DYNJ25605B, DYNJ25624B, DYNJ25645B, DYNJ25715, DYNJ25757B, DYNJ25792A, DYNJ25795, DYNJ25796A, DYNJ25821A, DYNJ25825B, DYNJ25827A, DYNJ25829A, DYNJ25831B, DYNJ25891D, DYNJ25896B, DYNJ25896B, DYNJ25908, DYNJ25925, DYNJ25929, DYNJ25935A, DYNJ25936A, DYNJ25941A, DYNJ25957, DYNJ25987B, DYNJ26045A, DYNJ26045A, DYNJ26078A, DYNJ26100A, DYNJ26123A, DYNJ26171C, DYNJ26172C, DYNJ26178A, DYNJ26181A, DYNJ26189, DYNJ26190A, DYNJ26191A, DYNJ26192B, DYNJ26193B, DYNJ26196A, DYNJ26197, DYNJ26237A, DYNJ26241B, DYNJ26257B, DYNJ26260A, DYNJ26277, DYNJ26278, DYNJ26289, DYNJ26294, DYNJ26294, DYNJ26325, DYNJ26394A, DYNJ26420A, DYNJ26448, DYNJ26453A, DYNJ26455, DYNJ26459B, DYNJ26566, DYNJ26570, DYNJ26573, DYNJ26608, DYNJ26635A, DYNJ26685, DYNJ26724A, DYNJ26726, DYNJ26730, DYNJ26732, DYNJ26733A, DYNJ26750, DYNJ26753, DYNJ26757, DYNJ26761, DYNJ26764, DYNJ26776, DYNJ26786B, DYNJ26848, DYNJ26848A, DYNJ26849A, DYNJ26850, DYNJ26852, DYNJ26853, DYNJ26873, DYNJ26891, DYNJ26901, DYNJ26901A, DYNJ26922, DYNJ26937, DYNJ26956A, DYNJ26964, DYNJ26964A, DYNJ26988, DYNJ26993, DYNJ27055, DYNJ27073, DYNJ27088, DYNJ27110, DYNJ27154, DYNJ27154, DYNJ27160, DYNJ27165, DYNJ27173, DYNJ27234, DYNJ27273, DYNJ27278, DYNJ27309, DYNJ27313, DYNJ27315, DYNJ27337, DYNJ27412, DYNJ27438, DYNJC1028F, DYNJC1030G, DYNJC1131B, DYNJC1254J, DYNJC1267F, DYNJC1361G, DYNJC1382D, DYNJC1517D, DYNJC1520C, DYNJC1541G, DYNJC1542C, DYNJC1639G, DYNJC1657G, DYNJC1748B, DYNJC1753F, DYNJC1754A, DYNJC1834G, DYNJC1877A, DYNJC1910F, DYNJC1912C, DYNJC1916B, DYNJC1981F, DYNJC1986N, DYNJC2023I, DYNJC2202N, DYNJC2229L, DYNJC2237A, DYNJC2274G, DYNJC2281F, DYNJC2287B, DYNJC2288, DYNJC2338B, DYNJC2373B, DYNJC2375B, DYNJC2393A, DYNJC2399A, DYNJC2413B, DYNJC2414B, DYNJC2418, DYNJC2419G, DYNJC2420D, DYNJC2422B, DYNJC2427B, DYNJC2431G, DYNJC2431I, DYNJC2460A, DYNJC2484C, DYNJC2485, DYNJC2588D, DYNJC2606G, DYNJC2684D, DYNJC2701A, DYNJC2714A, DYNJC2715A, DYNJC2758J, DYNJC2759I, DYNJC2760I, DYNJC2762J, DYNJC2763G, DYNJC2764G, DYNJC2766G, DYNJC2767I, DYNJC2768N, DYNJC2769I, DYNJC2794B, DYNJC2821, DYNJC2848C, DYNJC2915D, DYNJC2956D, DYNJC2985A, DYNJC2994D, DYNJC3091F, DYNJC3110C, DYNJC3117D, DYNJC3118G, DYNJC3137A, DYNJC3143G, DYNJC3184D, DYNJC3186C, DYNJC3187C, DYNJC3188D, DYNJC3191C, DYNJC3225C, DYNJC3256A, DYNJC3259B, DYNJC3276, DYNJC3279C, DYNJC3280B, DYNJC3292C, DYNJC3294A, DYNJC3299A, DYNJC3304A, DYNJC3349C, DYNJC3360A, DYNJC3362A, DYNJC3367C, DYNJC3380A, DYNJC3417, DYNJC3418, DYNJH1054I, DYNJH1060B, DYNJH1158A, DYNJH1223C, DYNJH1227A, DYNJH1235F, DYNJH1236, DYNJHS0116F, DYNJHS0145A, DYNJHS0181C, DYNJHS0570, DYNJHS0597A, DYNJHS0597B, DYNJHS0604C, DYNJHS0605C, DYNJHS0628, DYNJHS0709B, DYNJQ0009A, DYNJQ0020A, DYNJQ0029D, DYNJQ0043, DYNJQ0059F, DYNJQ0060B, DYNJQ0063B, DYNJQ0064F, DYNJQ0097A, DYNJQ0100A, DYNJQ0114, DYNJQ0118B, DYNJQ0119B, DYNJQ0120A, DYNJQ0123A, DYNJQ0124B, DYNJQ0127, DYNJQ0128A, DYNJQ0131A, DYNJQ0140C, DYNJQ0157D, DYNJQ0162B, DYNJQ0171A, DYNJQ0172, DYNJQ0177A, DYNJQ0178C, DYNJQ0180B, DYNJQ0185A, DYNJQ0191F, DYNJQ0207, DYNJQ0221, DYNJQ0226C, DYNJQ0227B, DYNJQ0234A, DYNJQ0235A, DYNJQ0237A, DYNJQ0240A, DYNJQ0242A, DYNJQ0244B, DYNJQ0271, DYNJQ0286D, DYNJQ0299A, DYNJQ0301A, DYNJQ0304A, DYNJQ0306B, DYNJQ0308B, DYNJQ0320A, DYNJQ0338A, DYNJQ0365A, DYNJQ0369A, DYNJQ0370A, DYNJQ0376B, DYNJQ0405A, DYNJQ0411A, DYNJQ0415, DYNJQ0439B, DYNJQ0461A, DYNJQ0486, DYNJQ0497, DYNJQ0508, DYNJQ0526, DYNJQ0529, DYNJQ0541A, DYNJQ0543, DYNJQ0564, DYNJQ0567, DYNJQ0578, DYNJQ0584, DYNJSB0013, DYNJT0017G, DYNJT0018I, DYNJT0019I, DYNJT0055B, DYNJT0056A, DYNJT0087B, DYNJT0162D, DYNJT0225C, DYNJT0258A, DYNJT0483A, DYNJT0505B, DYNJT0507F, DYNJT0616B, DYNJT0617A, DYNJT0627G, DYNJT1076G, DYNJT1077J, DYNJT1081G, DYNJT1083F, DYNJT1084B, DYNJT1085G, DYNJT1107B, DYNJT1185C, DYNJT1187F, DYNJT1259B, DYNJT1273, DYNJT1282B, DYNJT1299B, DYNJT1302B, DYNJT1416F, DYNJT1459, DYNJT1485B, DYNJT1589A, DYNJT1678A, DYNJT1679C, DYNJT1695A, DYNJT1745F, DYNJT1759B, DYNJT1877B, DYNJT1878, DYNJT1901C, DYNJT1926B, DYNJT1927A, DYNJT1936, DYNJT1938, DYNJT1943A, DYNJT1945A, DYNJT1947, DYNJT1972D, DYNJT2003, DYNJT2014C, DYNJT2110B, DYNJT2119A, DYNJT2121B, DYNJT2144A, DYNJT2159C, DYNJT2179, DYNJT2180D, DYNJT2185A, DYNJT2248A, DYNJT2262, DYNJT2388A, DYNJT2432A, DYNJT2444, DYNJT2445, DYNJT2484C, DYNJV0039F, DYNJV0067I, DYNJV0069C, DYNJV0071G, DYNJV0073C, DYNJV0076A, DYNJV0078C, DYNJV0079D, DYNJV0083C, DYNJV0098B, DYNJV0100D, DYNJV0107F, DYNJV0160C, DYNJV0196B, DYNJV0218, DYNJY0001A, DYNJY0003A, DYNJY0010, DYNJY0019B, DYNJY0041B, DYNJY0042A, DYNJY0050B, DYNJY0056B, DYNJY0057C, DYNJY0059B, DYNJY0060C, DYNJY0064D, DYNJY0067C, DYNJY0069, DYNJY0074B, DYNJY0075A, DYNJY0080A, DYNJY0083B, DYNJY0085A, DYNJY0090, DYNJY0097A, DYNJY0098A, DYNJY0102A, DYNJY0110B, DYNJY0112A, DYNJY0118B, DYNJY0119, DYNJY0121, DYNJY0130A, DYNJY0131A, DYNJY0135, DYNJY0141A, DYNJY0144, DYNJY0150A, DYNJY0151A, DYNJY0152A, DYNJY0153, DYNJY0162B, DYNJY0166A, DYNJY0167A, DYNJY0168, DYNJY0169, DYNJY0173B, DYNJY0179B, DYNJY0181B, DYNJY0183B, DYNJY0184B, DYNJY0186A, DYNJY0195A, DYNJY0203C, DYNJY0207B, DYNJY0210, DYNJY0216, DYNJY0217A, DYNJY0218A, DYNJY0220, DYNJY0221, DYNJY0222, DYNJY0225, DYNJY0227, DYNJY0228, DYNJY0236, DYNJY0238A, DYNJY0239, DYNJY0240, DYNJY0241, DYNJY0244B, DYNJY0246, DYNJY0247, DYNJY0254A, DYNJY0276, DYNJY0277.
RECALLING FIRM/MANUFACTURER
Medline Industries, Inc., Waukegan, IL, by letters dated March 4, 2005. Firm initiated recall is ongoing.
REASON
There is a potential for open side seals post-sterilization of the Tyvek breather pouches used in the custom sterile packs.
VOLUME OF PRODUCT IN COMMERCE
31,497 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Cold Therapy Blanket. Recall # Z-0577-05.
CODE
Item No. T230ST Codes: 2797009, 3030109, 3403577;
Item No. T330ST Codes: 2930674, 3030125, 3058048, 3138849, 3139008, 3153547, 3316254, 3373996, 3432079, 3754300, 3754300;
Item No. T332ST Codes: 2031177, 2031185, 2797041, 3007785, 3010351, 3086698, 3088511, 3139024, 3213845, 3223980, 3316262, 3355991, 3410312, 3454500, 3531421, 3632046, 3678554;
Item No. T332VQ Codes: 3138857, 3139032, 3357700, 3521805, 3531448;
Item No. T333ST Codes: 3018628, 3088520, 3155999, 3239471, 3285419, 3356002, 3403614, 3632054, 3670211;
Item No. T333VQ Codes: 2920450, 3030168, 3315631, 3440255, 3592970, 3614315;
Item No. T350VQ Codes: 2847395, 3207429, 3315649, 3592988, 3613574;
Item No. T5030ST Codes: 2930578, 3029950, 3043014, 3239244, 3282728, 3355894, 3403518;
Item No. T5030ST-10 Code: 3678431;
Item No. T5031ST Codes: 3057791, 3138902, 3153512, 3239287, 3284491, 3316060, 3373793, 3431990, 3451771, 3505961, 3545436, 3580557, 3631941, 3647871, 3659901, 3668698, 3713647;
Item No. T5031ST-10 Codes: 3315622, 3329776;
Item No. T5032ST Codes: 2852864, 2975696, 3088431, 3316107, 3373831, 3401951, 3410208, 3451780, 3531392, 3580581, 3678458;
Item No. T5032ST-10 Codes: 2796891, 3009115, 3086680, 3194293, 3207402, 3223947, 3373849, 3631991
Item No. T5032VQ Codes: 2796903, 2975717, 3138937, 3239332, 3316115, 3373857, 3432028, 3531405, 3580590, 3647918;
Item No. T5033ST Codes: 2904636, 2975750, 3153539, 3194314, 3239359, 3316131, 3355923, 3373873, 3432036, 3449022, 3451798, 3647926, 3698598;
Item No. T5033ST-10 Codes: 3030037, 3088458, 3088466, 3239367, 3285355, 3355931, 3403542, 3454462, 3521813, 3532900, 3596436, 3632003;
Item No. T5033VQ Codes: 2678801, 3239375, 3316140, 3401969, 3505995, 3531413, 3580602, 3647977;
Item No. T5040ST Codes: 2181491, 2320147, 2371278, 2430477, 2496871, 2678819, 2904644, 2994521, 3030045, 3088491, 3138953, 3194541, 3239383, 3254495, 3285363, 3440221, 3592937, 3632011, 3678466;
Item No. T5050ST Codes: 2736169, 2753701, 2796954, 2897325, 2975805, 3030053, 3057900, 3194322, 3239404, 3316174, 3449031, 3451827, 3506040, 3713663;
Item No. T5050ST-10 Codes: 1909831, 2975821, 3057942, 3316182;
Item No. T5050VQ Codes: 2678827, 2796971, 3057951, 3316191, 3647993;
Item No. T5090ST Codes: 2812011, 289725;
Item No. T530ST Codes: 2930682, 3030176, 3058072, 3402048; Item No. T531ST Code: 3402081;
Item No. T533ST Codes: 2753831, 3088554, 3402128;
Item No. T540ST Code: 2215216;
Item No. T590ST Codes: 1910081, 2320059, 2326485.
RECALLING FIRM/MANUFACTURER
DeRoyal Technologies, Inc., New Tazewell, TN, by letter on November 22, 2004. Firm initiated recall is ongoing.
REASON
There is a possibility of water leaking from the welded seam of the blanket.
VOLUME OF PRODUCT IN COMMERCE
5,084 units.
DISTRIBUTION
Nationwide and Mexico.

_______________________________
PRODUCT
Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System. Recall # Z-0578-05.
CODE
Serial numbers: 8, 960, 1341, 1343, 1344, 1351 through 1354, 1359, 1363, 1365 through 1368, 1372, 1379, 1581, 1583, 1584, 1589 through 1593, 1598, 1599, 1756, 1757, 1760, 1771, 1784, 1786, 1792, 1793, 2001, 2005, 2007, 2012 through 2018, 2020 through 2025, 2028, 2029, 2031, 2032, 2036, 2037, 2038, 2041, 2043, 2044, 2047, 2175, 2176, 2177, 2180 through 2187, 2189 through 2195, 2197, 2198, 2348, 2355 through 2370, 2372, 2373, 2374, 2375, 2376, 2378, 2381, 2382, 2389, 2390, 2392, 2393, 2400 through 2433, 2435, 2436, 2442, 2443, 2453, 2475, 2560, 2562, 2563, 2564, 2565, 2566, 2568, 2569, 2572 through 2579, 2590, 2592, 2593, 2595, 2596, 2597, 2598, and 2599.
RECALLING FIRM/MANUFACTURER
Sybaritic, Inc., Bloomington, MN, by telephone on January 5, 2005. Firm initiated recall is ongoing.
REASON
Device is performing functions that are not cleared in the 510(k).
VOLUME OF PRODUCT IN COMMERCE
152 units.
DISTRIBUTION
Nationwide and the Phillipines.

_______________________________
PRODUCT
PepGen P-15 Putty(0.5cc). Article Number: 99U200-005. Recall # Z-0579-05.
CODE
Lot Number:04P1017A.
RECALLING FIRM/MANUFACTURER
Dentsply Friadent Ceramed, Lakewood, CO, by letters dated February 17, 2005. Firm initiated recall is ongoing.
REASON
PepGen P-15 Putty kit was labeled with the incorrect expiration date.
VOLUME OF PRODUCT IN COMMERCE
250 kits.
DISTRIBUTION
Nationwide, Canada, and British Columbia.

_______________________________
PRODUCT
KinAir MedSurg, flotation therapy, powered hospital bed. Recall # Z-0583-05.
CODE
Serial Numbers KASK00001 through KASK01212.
RECALLING FIRM/MANUFACTURER
Kinetic Concepts, Inc., San Antonio, TX, by telephone on June 6, 2003. Firm initiated recall is complete.
REASON
Weld failure causes side rail welds to turn upside down or break off of the bed.
VOLUME OF PRODUCT IN COMMERCE
1,181 beds.
DISTRIBUTION
Nationwide and Brazil.

_______________________________
PRODUCT
a) BD Nexiva Closed IV Catheter System, 18 gauge.
Catalog Numbers: 383508, 383509. Recall # Z-0584-05;
b) BD Nexiva Closed IV Catheter System, 20 gauge.
Catalog Numbers: 383505, 383506, 383507. Recall
# Z-0585-05;
c) BD Nexiva Closed IV Catheter System, 22 gauge.
Catalog Number: 383502. Recall # Z-0586-05;
d) BD Nexiva Closed IV Catheter System, 24 gauge.
Catalog Numbers: 383500, 383501. Recall # Z-0587-05;
CODE
All Lot numbers.
RECALLING FIRM/MANUFACTURER
Becton Dickinson Infusion Therapy, Sandy, UT, by telephone on February 3, 2005, and letters dated February 10, 2005. Firm initiated recall is ongoing.
REASON
The Y-luer connection may crack during normal product use.
VOLUME OF PRODUCT IN COMMERCE
4,795 catheters.
DISTRIBUTION
IL, UT, TX, and FL.

_______________________________
PRODUCT
a) The product is a battery operated toothbrush.
Spinbrush Pro Whitening Ex Soft battery operated
toothbrushes UPC 76687800191. Recall # Z-0589-05;
b) The product is a battery operated toothbrush.
Spinbrush Pro Whitening Medium battery operated
toothbrushes UPC 76687800193. Recall # Z-0590-05;
c) The product is refill heads for battery powered
toothbrushes. Spinbrush Pro Whitening EX Soft
Refill Heads, UPC776687800192.Recall # Z-0591-05;
d) The product is refill heads for battery powered
toothbrushes. Spinbrush Pro Whitening Medium
Refill Heads, UPC776687800194.Recall # Z-0592-05;
e) The product is a Spinbrush Pro EX Soft battery
operated toothbrushes. UPC 76687800078.
Recall # Z-0593-05;
f) The product is a Spinbrush Pro Medium battery
operated toothbrushes. UPC 76687800079.
Recall # Z-0594-05;
g) The product is a Spinbrush Pro EX Soft battery
powered Refill heads for battery powered
toothbrushes. UPC 776687800080.
Recall # Z-0595-05;
h) The product is refill heads for battery powered
toothbrushes. Spinbrush Pro Medium Refill heads,
UPC 776687800081. Recall # Z-0596-05.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Proctor & Gamble CO., Cincinnati, OH, by letter dated February 23, 2005 and March 4, 2005. Firm initiated recall is ongoing.
REASON
The brushes may experience head breakage when insufficiently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate.
VOLUME OF PRODUCT IN COMMERCE
15 million toothbrushes and refill heads.
DISTRIBUTION
Nationwide, Guam, Puerto Rico, and Aruba.

_______________________________
PRODUCT
a) Medtronic Marquis VR, model 7230 Single Chamber
Implantable Cardioverter Defibrillator (ICD)
devices are tiered therapy implantable arrhythmia
control devices, which provide automatic detection
of ventricular arrhythmias and delivery of user-
selected therapies for the detected arrhythmia.
Therapies are automatically delivered following
detection or can be initiated via programming by the
physician. These ICDs are multi-programmable and have
the capability of transmitting via telemetry the
programmed values, measured and collected data, and
event markers. Recall # Z-0597-05;
b) Medtronic Maximo VR, model 7232 Single Chamber
Implantable Cardioverter Defibrillator (ICD).
Recall # Z-0598-05;
c) Medtronic Marquis DR, model 7274 Dual Chamber
Implantable Cardioverter Defibrillator (ICD).
Recall # Z-0599-05;
d) Medtronic InSync Marquis, model 7277 Dual Chamber
Implantable Cardioverter Defibrillator (ICD) with
Cardiac Resynchronization Therapy.
Recall # Z-0600-05;
e) Medtronic Maximo DR, model 7278 Single Chamber
Implantable Cardioverter Defibrillator (ICD).
Recall # Z-0601-05;
f) Medtronic InSync III Marquis, model 7279 Dual
Chamber Implantable Cardioverter Defibrillator
(ICD) with Cardiac Resynchronization Therapy.
Recall # Z-0602-05;
g) Medtronic InSync III Protect, model 7285 Dual
Chamber Implantable Cardioverter Defibrillator
(ICD) with Cardiac Resynchronization Therapy.
Recall # Z-0603-05;
h) Medtronic InSync II Marquis, model 7289 Dual
Chamber Implantable Cardioverter Defibrillator
(ICD) with Cardiac Resynchronization Therapy.
Recall # Z-0604-05.
CODE
a) (Serial numbers listed include all affected
devices but may include some unaffected devices.
Patients are recommended to check with their
doctor for exact serial numbers affected.)
7230B S-Series: PLW600001S - PLW600646S.
7230Cx H-Series: PKD100001H - PKD116584H,
PKD117397H, PKD117553H, PKD117735H, and PKD117741H.
R-Series: PKD200084R - PKD200536R, PKD600016R --
PKD600113R. S-Series: PKD600009S - PKD608391S.
7230E S-Series: PLY600001S - PLY600749S and
PLY600839S.
b) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) Q-Series:
PRN800001A - PRN800024Q. S-series PRN600001S --
PRN602430S and PRN604401S - PRN604831S;
c) (Serial numbers listed include all afffected
devices but may include some unaffected devices.
Patients are recommended to check with their
doctor for exact serial numbers affected.)
H-Series: PKC100001H - PKC138887H and PKC142234H.
R-series: PKC200320R - PKC200572R.
A-Series: PKC120001S - PKC120092S and PKC600001S --
PKC617090S.
d) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) H-Series: PLT100002H --
PLT100583H. S-Series: PLT600001S - PLT611901S;
e) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) Q-Series: PRM800001Q --
PRM800123Q. S-Series: PRM600001S - PRM605919S and
PRM606025S - PRM606035S;
f) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) Q-Series: PLU400002Q --
PLU400172Q and PLU800002Q - PLU800878Q.
S-Series: PLU600001S - PLU602739S and PLU800001S --
PLU800085S;
g) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for exact
serial numbers affected.) Q-Series: PPC800001Q --
PP800011Q. H-Series: PPC100002H - PPC100005H.
S-Series: PPC600001S - PPC600184S.
h) (Serial numbers listed include all affected devices
but may include some unaffected devices. Patients
are recommended to check with their doctor for
exact serial numbers affected.) S-Series: PRJ600001 --
PRJ609639S and PRJ614813 - PRJ614815S.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Cardiac Rhythm Management, Fridley, MN, by letter starting on February 10, 2005. Firm initiated recall is ongoing.
REASON
Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.
VOLUME OF PRODUCT IN COMMERCE
100,288 devices.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Roche brand ISE SnapPak for use only in the AVL
9120/9130 Electrolyte Analyzer. Ref/No. 03112276180;
Part number BP5016. Recall # Z-0605-05;
b) Roche brand ISE SnapPak for use only in the AVL
9180/9181 Electrolyte Analyzer; Ref/No. 03112349180,
Part number BP5186. Recall # Z-0606-05;
c) Roche brand ISE SnapPak for use only in the AVL
9110/9140 Electrolyte Analyzer; Ref/No. 03112314018,
Part number BP5032. Recall # Z-0607-05;
d) Bayer brand Technicon RA/opeRA Systems ISE Fluid
Pack for in vitro diagnostic use on the opera
system only, Manufacturer part number T01-3606-01,
Roche part number 03361322001. Recall # Z-0608-05;
e) Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid
Pack for use in the STARLYTE III electrolyte analyzer,
Roche part number 03361152001. Recall # Z-0609-05;
f) AVL Scientific Corp. brand 9180 SnapPak Type D,
BP5206, for use only in the AVL 9180 electrolyte
analyzer, Roche part number 03112357182.
Recall # Z-0610-05;
g) Vital Scientific brand ISE Snap Pack for use only
in the ISE Module 9130, Ref no. 3203-007, Roche part
number 03522032001. Recall # Z-0611-05.
CODE
a), b), c), d), e) All units;
f) All units. (Sold only outside of the U.S.
by Sysmex in Japan.);
g) All units. (Sold only outside of the U.S.
by Vital in Netherlands).
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, by letters dated December 21, 2004 and January 3, 2005. Firm initiated recall is ongoing.
REASON
A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.
VOLUME OF PRODUCT IN COMMERCE
137,037 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
a) CryoValve, Pulmonary Valve & Conduit. Donor #62654,
Model #PV00. Recall # Z-0580-05;
b) CryoValve, Aortic Valve and Conduit. Donor #62654,
Model #AV00. Recall # Z-0581-05.
CODE
a) Serial #7816169;
b) Serial #7816174.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on December 17, 2004. Firm initiated recall is ongoing.
REASON
Records noted that the infant donor's mother had tested positive for Hepatitis B.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
CA, and FL.

_______________________________
PRODUCT
Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm). Recall # Z0582-05.
CODE
Lot 1152181, Exp 10-2009.
RECALLING FIRM/MANUFACTURER
Teleflex Medical, Bannockburn, IL, by letter dated January 14, 2005. Firm initiated recall is ongoing.
REASON
Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.
VOLUME OF PRODUCT IN COMMERCE
8,990 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S. Recall # Z-0588-05.
CODE
Lot # L0104244.
RECALLING FIRM/MANUFACTURER
Cordis Corporation, Miami Lakes, FL, by letter dated April 30, 2004. Firm initiated recall is complete.
REASON
The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters.
VOLUME OF PRODUCT IN COMMERCE
40.
DISTRIBUTION
FL, OK, SC, and KS, South Africa and the Netherlands.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS I

_______________________________
PRODUCT
High Noon Oklahoma Mix Medicated, For Lambs Weighing Up to 50 Lbs., containing 90 g/ton lasalocid, packaged in 50-lb. bags. Recall # V-040-5.
CODE
Lot #E10250604.
RECALLING FIRM/MANUFACTURER
High Noon Feeds, LLC, Bird City, KS, by telephone on November 4, 2004 and December 5, 2004. Firm initiated recall is complete.
REASON
The lot was superpotent.
VOLUME OF PRODUCT IN COMMERCE
80/50-lb. bags.
DISTRIBUTION
KS, and CO.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

_______________________________
PRODUCT
High Noon Oklahoma Mix Medicated, For Lambs Weighing Up to 50 Lbs., containing 90 g/ton lasalocid, packaged in 50-lb. bags. Recall # V-041-5.
CODE
Lot #E07210404.
RECALLING FIRM/MANUFACTURER
High Noon Feeds, LLC, Bird City, KS, by telephone on November 4, 2004 and December 5, 2004. Firm initiated recall is complete.
REASON
The lot was subpotent.
VOLUME OF PRODUCT IN COMMERCE
80/50-lb. bags.
DISTRIBUTION
KS, and CO.

END OF ENFORCEMENT REPORT FOR MARCH 16, 2005

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