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U.S. Department of Health and Human Services

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Enforcement Report for August 22, 2007

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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August 22, 2007
07-34

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS I

___________________________________
PRODUCT
a) WholeSoy & Co. Blueberry Soy Yogurt, in 6oz plastic cup, Keep Refrigerated.
    Manufacturing Dates are 4/23/07 and (not through) 4/30/07, Recall # F-469-7;
b) WholeSoy & Co. Mixed Berry Soy Yogurt, in 6oz plastic cup, Keep Refrigerated.
    Manufacturing Dates are 4/23/07 and (not through) 4/30/07, Recall # F-470-7
CODE
Both products are coded with best by dates of June 22 and June 29.
RECALLING FIRM/MANUFACTURER
Recalling Firm: WholeSoy & Co., San Francisco, CA, by telephone, email, fax, and press release beginning on June 1, 2007.
Manufacturer: Super Store Industries, Turlock, CA. Firm initiated recall is ongoing.
REASON
Products contain undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
7,285 cases (12-6 oz cups per case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Rajmoti brand Indian Hulled Sesame Seeds, Recall # F-471-7
CODE
Lot: 31508
RECALLING FIRM/MANUFACTURER
Recalling Firm: Woodhouse Commodities, Woodland Hills, CA, by telephone and e-mail on May 1, and May 3, 2007.
Manufacturer: Utsav Overseas Pvt. Ltd, Jalgaon, India. Firm initiated recall is complete.
REASON
FDA’s analysis found the product contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
839 – 50 lb bags
DISTRIBUTION
NV
___________________________________
PRODUCT
Market Basket Complete Just Add Water Pancake & Waffle Mix; 32 oz (2 lb) 907g box,12 boxes per case; UPC 0  49705 14852 5, Recall # F-472-7
CODE
Expiration date: 08 29 07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Karlin Foods, Northfield, IL, by telephone and e-mail on July 9, 2007 and by press release on July 10, 2007.
Manufacturer: Little Crow Milling Co., Inc., Warsaw, IN. Firm initiated recall is complete.
REASON
The pancake mix contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
1,435 cases (12 boxes/case)
DISTRIBUTION
MA and NH
___________________________________
PRODUCT
King Chief Dried Lily Flowers, net wt. 6 oz. (170g), UPC 6 868978 722362. Serving size: 1 cup (11g), Servings per container: About 16. The product is packaged in a sealed, flexible plastic bag, Recall # F-476-7 
CODE
No code
RECALLING FIRM/MANUFACTURER
Domega International Ltd., Inc., Brooklyn, NY, by press and letter on May 30, 2007. Firm initiated recall is complete.
REASON
The product contains undeclared sulfites (7528 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
129 cases (100 – 6 oz. bags per case)
DISTRIBUTION
Nationwide and Jamaica

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS II
___________________________________
PRODUCT
a) Nodine's Smokehouse Smoked Idaho Trout, Ready to Eat, various sizes.
    Vacum packed and refrigerated UPC: 2923700620, Recall # F-473-7
b) Nodine's Smokehouse Smoked Idaho Trout Fillet, Ready to Eat, various sizes.
    Vacum packed and refrigerated UPC: 2923700620, Recall # F-474-7
c) Nodine's Smokehouse Smoked Peppered Bluefish, Ready to Eat, various sizes.
    Vacum packed and refrigerated UPC: 2923700602, Recall # F-475-7
CODE
a) 0867, 1107;
b) 0867, 1107 and 1367;
c) 0787
RECALLING FIRM/MANUFACTURER
Nodine’s Smokehouse, Inc., Torrington, CT, by letter on June 4, 2007. Firm initiated recall is ongoing.
REASON
Product contains undeclared sulfites
VOLUME OF PRODUCT IN COMMERCE
277 lbs
DISTRIBUTION
CT, FL, MA, ME, MN, NY, PA

RECALLS AND FIELD CORRECTIONS:  FOODS AND COSMETICS - CLASS III
___________________________________
PRODUCT
Well Source Bottle Water. The product was sold under the Hampton Inn label in 16.9 fl. oz. (500 ml) bottles and under the Wio label in 16.9 fl. oz. (500 ml), 20 oz. (591 mL), 33.8 fl. oz. (1 Liter), and 1 gallon (3.78L) sizes. NYSHD Cert. # 455, Recall # F-466-7
CODE
All product produced in June 2007.
RECALLING FIRM/MANUFACTURER
HGW Enterprises, LLC, Harford, NY, by visit beginning on July 27, 2007. Firm initiated recall is ongoing.
REASON
Bottled water exceeds the federal limit for bromate of 10 ppb. Testing results ranged from 29.7 ppb to 39.7 ppb.
VOLUME OF PRODUCT IN COMMERCE
16.9 oz. – 2033 bottles; 20 oz. 1531 bottles; 1 Liter – 1111 bottles; 1 gallon – 418 bottles
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I

___________________________________
PRODUCT
Long Weekend, Natural Libido Enhancer, (Epimedium P.E. 300 mg, Fructus Lycii P. E. 50 mg), A Dietary Supplement, 3 capsules/box, UPC 809515-0542, Recall # D-951-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Confidence, Inc., Port Washington, NY, by telephone on June 6, 2007 and by press release on June 14, 2007. Firm initiated recall is ongoing.
REASON
Unapproved new drug; product was found to contain undeclared tadalafil, the active pharmaceutical ingredient in an FDA-approved drug used to treat erectile dysfunction.
VOLUME OF PRODUCT IN COMMERCE
Approximately 4,772 capsules
DISTRIBUTION
Nationwide, Canada, UK, Russia, Spain and China

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT
ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 and 1000 count bottles, Rx only. NDC 0832-0302-00 and 0832-0302-01, Recall # D-952-2007
CODE
237011, 238568, 237005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Upsher Smith Laboratories, Inc., Maple Grove, MN, by telephone and letter on July 23, 2007.
Manufacturer: Upsher Smith Laboratories, Inc., Denver, CO. Firm initiated recall is ongoing.
REASON
Upsher-Smith Chlorpromazine Hydrochloride 50 mg tablets, USP may contain an illegible or missing imprint on tablet.
VOLUME OF PRODUCT IN COMMERCE
6,892
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10 mg, 100 count bottles, Rx only, NDC 63304-909-01, Recall # D-956-2007
CODE
Lot: CPE694, Expiration date: 5/2008
RECALLING FIRM/MANUFACTURER
Corepharma LLC, Middlesex, NJ, by letter on June 12, 2007. Firm initiated recall is ongoing.
REASON
GMP deviation. Failed blend uniformity requirement
VOLUME OF PRODUCT IN COMMERCE
7,420 bottles of 100
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1325-07
CODE
Units: 9566081, 8460071
RECALLING FIRM/MANUFACTURER
Life Share Blood Centers, Monroe, LA, by letter dated September 15, 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
LA
__________________________________
PRODUCT
Red Blood Cells, Recall # B-1344-07
CODE
Units: 0993075, 0955614
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by letters dated May 20, 2005. Firm initiated recall is complete.
REASON
Red Cells, collected from a donor who was taking Parlodel, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Whole Blood Leukocytes Reduced, Recall # B-1361-07
CODE
Unit: LS97828
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on June 23, 2003. 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-1363-07;
b) Cryoprecipitated AHF, Recall # B-1364-07;
c) Plasma Frozen Cryoprecipitate Reduced, Recall # B-1365-07
CODE
a), b), and c) Unit: 22LY98411
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey, Philadelphia, PA, by letter dated February 21, 2007. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who was previously deferred for testing repeat reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
PA
___________________________________
PRODUCT
Source Plasma, Recall # B-1366-07
CODE
Units: 19581415, 19650104, 10280041, 08703514, 08319050, 08314789
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc., Memphis, TN, by fax, on September 21, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for an unknown reason, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma, Recall # B-1367-07
CODE
Units: 08513403, 08510730, 09062283, 09061125
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc., Memphis, TN, by fax, on March 24, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for an unknown reason, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1368-07
CODE
Unit: C60066
RECALLING FIRM/MANUFACTURER
HCSB Blood Center, Bethlehem, PA, by telephone on January 23, 2007, and by letter dated February 9, 2007,. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who may have been at increased risk for human immunodeficiency virus (HIV) Group O, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Source Plasma, Recall # B-1369-07
CODE
Unit: 19731360
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc., Memphis, TN, by fax on October 28, 2004. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after the donor subsequently tested positive for Hepatitis C virus (HCV) by nucleic acid testing (NAT), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukoreduced, Recall # B-1370-07
CODE
Units: 04FX13050
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New England Region, Dedham, MA, by letter on February 28, 2007. 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
MA
___________________________________
PRODUCT
Red Blood Cells Leukoreduced, Recall # B-1373-07
CODE
Unit: LK01295
RECALLING FIRM/MANUFACTURER
Blood Centers of Wisconsin, Inc., Milwaukee, WI, by fax on June 18, 2003. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after the donor provided post-donation medical history information, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1386-07
CODE
Unit: 3955300
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on December 19, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on residence in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
__________________________________
PRODUCT
a) Soft Tissue - Bone Tendon Bone - Hemi w/Quadricep, Recall # B-1397-07;
b) Soft Tissue - Anterior Tibialis Tendon, Recall # B-1398-07;
c) Soft tissue- semitendinosus Tendon, Recall # B-1399-07;
d) Soft tissue - Bone Tendon Bone, Hemi w/Quadricep, Recall # B-1400-07;
e) Soft Tissue- Posterior Tibialis Tendon, Recall # B-1401-07;
f) Soft Tissue - Fascia Lata, Recall # B-1402-07;
g) Soft tissue- Achilles Tendon, Recall # B-1403-07
CODE
a) Units: 041624351033p, 041624351026p;
b) 041624351023p, 041624351029p;
c) Unit: 041624351025p;
d) Units: 041624351027p; 041624351034p;
e) Units: 041624351024P; 041624351030P;
f) Unit: 041624351028p;
g) Unit: 041624351032p
RECALLING FIRM/MANUFACTURER
Musculoskeletal Transplant Foundation, Edison, NJ, by telephone, on June 15, 2007 and by letter on June 25, 2007. Firm initiated recall is complete.
REASON
Tissues, associated with positive microbiological results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
WI, NY, MA, MI, MS, SC, VT, NJ, CT

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1324-07
CODE
Unit: 5810989
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone and fax, on March 21, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT
a) Platelets Pheresis, Leukocyted Reduced, Recall # B-1371-07;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1372-07
CODE
a) 04GR38332 (Parts 1 & 2), 04P62933 (Parts 1 & 2);
b) Units: 04LP71037 (Part 2), 04P62912 (Part 2), 04P62916 (Part 2)
RECALLING FIRM/MANUFACTURER
American Blood Services, New England Region, Dedham, MA, by fax on March 1, 2007. Firm initiated recall is complete
REASON
Platelets, which were not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MA, NY, NJ

___________________________________
PRODUCT
a) Cryoprecipitated AHF, Recall B-1374-07;
b) Red Blood Cells, Recall B-1375-07;
c) Plasma, Recall B-1376-07;
d) Platelet, Recall # B-1377-07;
e) Fresh Frozen Plasma, Recall # B-1378-07;
f) Red Blood Cells, Leukoreduced, Recall # B-1379-07;
g) Plasma Frozen Cryoprecipitate Reduced, Recall # B-1380-07;
h) Red Blood Cells Irradiated, Recall # B-1381-07;
i) Red Blood Cells, Leukoreduced, Irradiated, Recall # B-1382-07
CODE
a) Units: 032KQ61711 032KQ49797 032KQ49820 032KE00648 032KJ66653 032KQ49218
    032KQ61195 032KE00645 032KE02236 032KQ23909 032KQ29294 032GL57466 032KQ10561
    032KQ15519 032GE33097 032GE33098 032GE33099 032GE33101 032GE33102 032KN00527
    032KE00646 032KE19359 032KQ97511 032KQ62823 032KQ29299 032KQ29302 032KY15323
    032GE48964 032KQ56587 032KQ61884 032KJ92366 032KQ29309 032KQ68309 032KR02572;
b) Units: 032GK86546 032GK86547 032GL57466 032GR03799 032GR03801 032GR03803
    032GR03808 032GR03809 032GR03810 032GR03811 032GR03812 032GR03813 032GR03815
    032GR11363 032GR16681 032KC01155 032KC01477 032KC03974 032KC04392 032KC04400
    032KC04772 032KC04898 032KC06482 032KC06484 032KC06485 032KC06581 032KC06847
    032KC08106 032KC11021 032KC18365 032KC18366 032KC19409 032KC19411 032KE00170
    032KE00561 032KE00562 032KE00570 032KE00572 032KE00573 032KE00576 032KE00578
    032KE00586 032KE00638 032KE00641 032KE00642 032KE00643 032KE00645 032KE00646
    032KE00648 032KE02236 032KE02238 032KE03250 032KE06069 032KE06071 032KE09681
    032KE09989 032KE10012 032KE10013 032KE10015 032KE10016 032KE10017 032KE10018
    032KE10019 032KE10021 032KE10022 032KE10023 032KE10030 032KE10031 032KE10035
    032KE10036 032KE10037 032KE10038 032KE10039 032KE10040 032KE10041 032KE10042
    032KE10043 032KE10045 032KE10048 032KE10050 032KE10096 032KE10102 032KE10103
    032KE10106 032KE10107 032KE10109 032KE10110 032KE10114 032KE10115 032KE10123
    032KE11895 032KE12780 032KE13619 032KE13620 032KE13621 032KE13622 032KE13623
    032KE13625 032KE13639 032KE13640 032KE16069 032KE16558 032KE17716 032KE17753 
    032KE18571 032KE19359 032KE19779 032KE19780 032KE20681 032KE20682 032KE20683
    032KE20684 032KE20687 032KE21829 032KE21831 032KE21832 032KE21838 032KE21853
    032KE24190 032KE24218 032KE24220 032KE24221 032KE24222 032KE24223 032KE24225
    032KE24226 032KE25341 032KE26758 032KE26852 032KE26853 032KE26854 032KE26855
    032KE26856 032KE27647 032KE31551 032KE31779 032KE31928 032KE31930 032KE31932
    032KE31934 032KE31935 032KE31937 032KE32147 032KE32149 032KE32150 032KE32152
    032KE32153 032KE32606 032KE32608 032KE32609 032KE32610 032KE32611 032KE32612
    032KE33020 032KE33120 032KE35025 032KE35027 032KE35028 032KE35038 032KE35688
    032KE35691 032KE35692 032KE35693 032KE35694 032KE35698 032KE35701 032KE35702
    032KE35703 032KE36860 032KE38784 032KE38785 032KE38787 032KE38788 032KE38796
    032KE38797 032KE38798 032KE38800 032KE38801 032KE38803 032KE38804 032KE38845
    032KE40268 032KE40270 032KE42337 032KF58001 032KF60982 032KF60983 032KF64672
    032KF65655 032KF65657 032KF65658 032KF65659 032KF65660 032KF65661 032KF65662
    032KF65663 032KF65665 032KF65667 032KF65668 032KF65669 032KF65672 032KF65678
    032KF65679 032KF65683 032KF65720 032KF65721 032KF67388 032KF72316 032KF72318
    032KF73882 032KF76154 032KF80676 032KF81053 032KF82133 032KF84127 032KF85344
    032KF87550 032KF88828 032KH83810 032KH84697 032KH84856 032KH86284 032KH91282
    032KH92779 032KH92787 032KH96951 032KH98275 032KJ48405 032KJ48407 032KJ48409
    032KJ48410 032KJ48411 032KJ48412 032KJ48413 032KJ48414 032KJ48417 032KJ48419
    032KJ48420 032KJ48421 032KJ48422 032KJ49797 032KJ54117 032KJ54587 032KJ54588
    032KJ54589 032KJ54592 032KJ54593 032KJ54595 032KJ57026 032KJ61166 032KJ61923
    032KJ61924 032KJ61928 032KJ61929 032KJ61930 032KJ61931 032KJ61932 032KJ61933
    032KJ61935 032KJ61936 032KJ61940 032KJ61946 032KJ61947 032KJ62415 032KJ64798
    032KJ65664 032KJ65719 032KJ66535 032KJ66542 032KJ67104 032KJ67588 032KJ68242
    032KJ68245 032KJ68246 032KJ68248 032KJ68258 032KJ68261 032KJ68266 032KJ68513
    032KJ73169 032KJ73171 032KJ73172 032KJ73185 032KJ73186 032KJ73187 032KJ73188
    032KJ73190 032KJ73191 032KJ73193 032KJ76750 032KJ76828 032KJ77150 032KJ77546
    032KJ77550 032KJ77552 032KJ78183 032KJ81769 032KJ81781 032KJ82854 032KL04774
    032KL07101 032KL07337 032KL07854 032KL07856 032KM16339 032KM16341
    032KM16342 032KM16343 032KM16344 032KM16345 032KM16346 032KM16347
    032KM16348 032KM17196 032KM25278 032KQ09159 032KQ09161 032KQ09163
    032KQ09174 032KQ09189 032KQ09283 032KQ09284 032KQ09285 032KQ09286
    032KQ09290 032KQ09295 032KQ09296 032KQ09413 032KQ09626 032KQ09990
    032KQ10029 032KQ10033 032KQ10059 032KQ10561 032KQ14014 032KQ14881
    032KQ14892 032KQ14893 032KQ14897 032KQ14909 032KQ15320 032KQ15519
    032KQ15884 032KQ15886 032KQ15888 032KQ15890 032KQ15902 032KQ23094
    032KQ23889 032KQ23890 032KQ23891 032KQ23892 032KQ23893 032KQ23894
    032KQ23895 032KQ23909 032KQ24116 032KQ24131 032KQ24135 032KQ24156
    032KQ24158 032KQ24159 032KQ24160 032KQ24161 032KQ24162 032KQ24163
    032KQ24165 032KQ24223 032KQ24992 032KQ24993 032KQ24996 032KQ24998
    032KQ25010 032KQ25210 032KQ25211 032KQ26063 032KQ26064 032KQ26065
    032KQ26066 032KQ26497 032KQ27876 032KQ29239 032KQ29241 032KQ29242
    032KQ29244 032KQ29245 032KQ29294 032KQ29299 032KQ29302 032KQ29306
    032KQ29309 032KQ29776 032KQ29823 032KQ29885 032KQ31193 032KQ31194
    032KQ31195 032KQ31220 032KQ31258 032KQ32730 032KQ32868 032KQ32871
    032KQ32873 032KQ32874 032KQ32877 032KQ32878 032KQ32879 032KQ32880
    032KQ33120 032KQ33124 032KQ33127 032KQ33138 032KQ33439 032KQ33693
    032KQ33890 032KQ33927 032KQ33989 032KQ34322 032KQ34409 032KQ34444
    032KQ34445 032KQ34446 032KQ34447 032KQ34453 032KQ34454 032KQ34456
    032KQ34457 032KQ34458 032KQ34460 032KQ34461 032KQ34851 032KQ35210
    032KQ36136 032KQ38884 032KQ39079 032KQ39125 032KQ39244 032KQ40733
    032KQ40735 032KQ41198 032KQ43492 032KQ44188 032KQ44189 032KQ44191
    032KQ44192 032KQ44195 032KQ44196 032KQ44197 032KQ44202 032KQ44203
    032KQ44205 032KQ44232 032KQ44233 032KQ44234 032KQ44945 032KQ44984
    032KQ45893 032KQ49218 032KQ49792 032KQ49798 032KQ49802 032KQ49807
    032KQ51478 032KQ51778 032KQ51799 032KQ53355 032KQ53356 032KQ53374
    032KQ53375 032KQ54605 032KQ55289 032KQ56586 032KQ57980 032KQ57982
    032KQ57988 032KQ57989 032KQ57990 032KQ57991 032KQ57997 032KQ58454
    032KQ58461 032KQ58462 032KQ59145 032KQ59396 032KQ59397 032KQ59404
    032KQ59406 032KQ59409 032KQ59410 032KQ59411 032KQ59758 032KQ60554
    032KQ60556 032KQ60758 032KQ61195 032KQ61711 032KQ61882 032KQ61917
    032KQ62063 032KQ62064 032KQ62065 032KQ62067 032KQ62069 032KQ62420
    032KQ62427 032KQ62467 032KQ62637 032KQ62823 032KQ62911 032KQ64960
    032KQ65525 032KQ65537 032KQ65741 032KQ68290 032KQ68291 032KQ68293
    032KQ68297 032KQ68318 032KQ68338 032KQ68353 032KQ68493 032KQ68803
    032KQ68807 032KQ68808 032KQ68812 032KQ68813 032KQ68814 032KQ68815
    032KQ68817 032KQ68830 032KQ68831 032KQ68832 032KQ69121 032KQ69123
    032KQ69145 032KQ69149 032KQ69150 032KQ69251 032KQ69260 032KQ69261
    032KQ69262 032KQ69263 032KQ69264 032KQ69265 032KQ69273 032KQ75179
    032KY11476 032KY11729 032KY13983 032KY14838 032KY15020 032KY15267
    032KY15323;
c) Units: 032KE00645 032KE00648 032KE02236 032KF65657 032KF65672 032KH88052
    032KJ58222 032KQ14881 032KQ14893 032KQ14897 032KQ14898 032KQ14899
    032KQ14909 032KQ15519 032KQ15885 032KQ15890 032KQ23094 032KQ23889
    032KQ23891 032KQ23895 032KQ26497 032KQ33989 032KQ34322 032KY11552;
d) Units: 032KC04898 032KF64672;
e) Units: 032GK86545 032GK86547 032GK86548 032KC04898 032KC11582 032KC17712
    032KC19412 032KC20707 032KC22977 032KC26727 032KE02238 032KE10098
    032KE17173 032KE19780 032KE21853 032KE22117 032KE23455 032KE23456
    032KE35025 032KE35027 032KE35028 032KE35034 032KE35038 032KF65653
    032KF65676 032KF65678 032KF87550 032KF92632 032KF92635 032KF93898
    032KH83810 032KH84856 032KH92787 032KH98275 032KJ78183 032KM16340
    032KM16348 032KM25289 032KM25292 032KQ29776 032KQ32873 032KQ34851
    032KQ36136 032KQ53935 032KQ57991 032KQ59413 032KQ59415 032KQ64960
    032KQ65537 032KQ68913 032KT00338 032KT02615 032KT04175 032KY11476
    032KY15020 032KY15227 032KY15267;
f) Units: 032GE33096 032GE33097 032GE33098 032GE33099 032GE33101 032GE33102
    032GE34559 032GE41608 032GE42731 032GE45000 032GE46826 032GE48964 032GF48402
    032GK86545 032GK86548 032GR03800 032GR16680 032GR41881 032KC06483 032KC11026
    032KC11582 032KC11584 032KC11593 032KC17712 032KC19309 032KC19312 032KC20523
    032KC20634 032KC20707 032KC22044 032KC25741 032KC26395 032KC26402 032KC26404
    032KC26406 032KC26463 032KC26477 032KC26480 032KC26725 032KE00563 032KE00564
    032KE00567 032KE00569 032KE00574 032KE00575 032KE00579 032KE00581 032KE00582
    032KE00590 032KE00593 032KE03213 032KE06057 032KE10020 032KE10032 032KE10034
    032KE10044 032KE10047 032KE10049 032KE10095 032KE10097 032KE10100 032KE10101
    032KE10104 032KE10108 032KE10111 032KE10112 032KE10117 032KE10126 032KE17173
    032KE20679 032KE20680 032KE20688 032KE20690 032KE21830 032KE23455 032KE23456
    032KE23457 032KE23517 032KE31550 032KE31929 032KE31931 032KE31933 032KE32135
    032KE32136 032KE32144 032KE32148 032KE32151 032KE35034 032KE35690 032KE35696
    032KE35697 032KE35700 032KE36737 032KE38783 032KE38817 032KE40269 032KE44361
    032KE44542 032KE44567 032KE45431 032KE46659 032KE46660 032KE46662 032KE46663
    032KE46665 032KE46666 032KE46667 032KE46669 032KE46670 032KE47140 032KE47145
    032KE47784 032KE48598 032KE48896 032KE51369 032KE51373 032KE51883 032KE51884
    032KE51885 032KE51886 032KE53221 032KE53310 032KE53751 032KE56121 032KE57856
    032KE58365 032KE58464 032KE58794 032KE59321 032KE59322 032KE59840 032KE64175
    032KE64195 032KF62823 032KF65653 032KF65664 032KF65666 032KF65671 032KF65674
    032KF65676 032KF65677 032KF65681 032KF65724 032KF72317 032KF72319 032KF72320
    032KF82410 032KF82640 032KF87844 032KF87850 032KF92632 032KF92635 032KF93898
    032KF96668 032KF96669 032KF96670 032KF97779 032KF99400 032KF99793 032KF99794
    032KH92778 032KH96941 032KJ48427 032KJ54590 032KJ61922 032KJ61925 032KJ61927
    032KJ61934 032KJ61939 032KJ61942 032KJ61943 032KJ61945 032KJ61948 032KJ66653
    032KJ68243 032KJ68247 032KJ68249 032KJ69492 032KJ69592 032KJ69594 032KJ70017
    032KJ70018 032KJ70023 032KJ70027 032KJ70030 032KJ70032 032KJ70034 032KJ72621
    032KJ72622 032KJ72624 032KJ73189 032KJ73195 032KJ76830 032KJ77547 032KJ77549
    032KJ77553 032KJ79287 032KJ81632 032KJ81768 032KJ81771 032KJ81772 032KJ82867
    032KJ83653 032KJ85258 032KJ85327 032KJ85328 032KJ85329 032KJ85330 032KJ85331
    032KJ85332 032KJ86702 032KJ86771 032KJ86773 032KJ86779 032KJ86780 032KJ86781
    032KJ86784 032KJ88268 032KJ88271 032KJ88272 032KJ88273 032KJ88278 032KJ88282
    032KJ88287 032KJ88288 032KJ88289 032KJ88291 032KJ88293 032KJ88294 032KJ88295
    032KJ88296 032KJ90343 032KJ91005 032KJ91882 032KJ91883 032KJ91884 032KJ92366
    032KJ93090 032KJ94244 032KJ94384 032KJ95583 032KL03440 032KL05014 032KL05445
    032KL07523 032KL08582 032KL08742 032KL08743 032KL09164 032KL09165 032KL09278
    032KL09279 032KM16338 032KM16340 032KM25289 032KM25292 032KM25293
    032KM28597 032KM29598 032KM29707 032KM29883 032KM30667 032KN00524
    032KN00527 032KN00988 032KN02725 032KN04706 032KN05617 032KN05655
    032KQ09164 032KQ09405 032KQ09407 032KQ09410 032KQ09412 032KQ09414                        
    032KQ09418 032KQ09420 032KQ24995 032KQ25006 032KQ25212 032KQ31201
    032KQ32869 032KQ32881 032KQ34443 032KQ34448 032KQ34450 032KQ34452
    032KQ34498 032KQ35192 032KQ37310 032KQ39058 032KQ39082 032KQ40079
    032KQ44190 032KQ44193 032KQ44194 032KQ44198 032KQ44211 032KQ45744
    032KQ45750 032KQ45754 032KQ45758 032KQ46449 032KQ46508 032KQ49797
    032KQ49820 032KQ50078 032KQ51471 032KQ51776 032KQ51777 032KQ51788
    032KQ51791 032KQ51792 032KQ51800 032KQ51801 032KQ52048 032KQ52049
    032KQ52050 032KQ52051 032KQ52052 032KQ52085 032KQ53340 032KQ53342
    032KQ53361 032KQ53935 032KQ54226 032KQ54236 032KQ54240 032KQ54241
    032KQ54242 032KQ54243 032KQ54245 032KQ54247 032KQ54248 032KQ54249
    032KQ54250 032KQ54251 032KQ54253 032KQ54255 032KQ54256 032KQ54258
    032KQ54260 032KQ54262 032KQ54265 032KQ54438 032KQ56587 032KQ57979
    032KQ57992 032KQ59146 032KQ59413 032KQ59415 032KQ60891 032KQ61884
    032KQ63228 032KQ63719 032KQ66813 032KQ68269 032KQ68289 032KQ68299
    032KQ68309 032KQ68317 032KQ68323 032KQ68823 032KQ68913 032KQ68914
    032KQ68915 032KQ68917 032KQ68919 032KQ69117 032KQ69118 032KQ69124
    032KQ69126 032KQ69146 032KQ69148 032KQ69151 032KQ69153 032KQ73705
    032KQ75185 032KQ76087 032KQ76887 032KQ77689 032KQ77699 032KQ78943
    032KQ78967 032KQ78984 032KQ78988 032KQ80649 032KQ80659 032KQ82722
    032KQ83004 032KQ83005 032KQ84516 032KQ84942 032KQ85044 032KQ85049
    032KQ87436 032KQ87820 032KQ87890 032KQ87894 032KQ88532 032KQ88534
    032KQ88547 032KQ89335 032KQ90523 032KQ93583 032KQ93584 032KQ93590
    032KQ94832 032KQ95787 032KQ96064 032KQ97511 032KQ97663 032KQ97674
    032KQ97692 032KQ97754 032KQ97768 032KQ97769 032KQ98923 032KQ99728
    032KQ99752 032KR01626 032KR01804 032KR01805 032KR02096 032KR02097
    032KR02150 032KR02151 032KR02152 032KR02154 032KR02540 032KR02572
    032KR02609 032KR05825 032KR07048 032KS00053 032KS00383 032KT00177
    032KT00231 032KT05951 032KY14614 032KY14615 032KY14828 032KY15227
    032KY15816 032KY15917 032KY17713 032KY18774 032KY19007 032KY19010
    032LL90214 032LL90215 032LL90216 032LL90219 032LL90220 032LL90222
    032LL90227 032LX11604 032LX11605 032LX17964 032LX18933 032LX20129
    032LX20137 032LX20765 032LX20767 032LX20784 032LX20792;
g) Units: 032KJ66653 032KQ49218 032KQ61711 032KQ68309 032KQ97511;
h) Unit: 032KY11552;
i) Unit: 032KE10099 032KE44365 032KF65670 032KJ70031 032KQ14898 032KQ44235
    032KQ54252
RECALLING FIRM/MANUFACTURER
American Red Cross, Madison, WI, by telephone or fax beginning April 9, 2003 and by letter on April 11, 2003. Firm initiated recall is complete
REASON
Blood products, which were not prepared within the appropriate time frame after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1,149 units
DISTRIBUTION
WI, GA, IL, MD, AL, IA, NC, OH, MA, MI, CT, IN, FL, AR, CA, TN, PA, PR, MN

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
a) GE Medical Systems Mac-Lab System, cardiac catheterization data system.
    Software Version 6.5 2021423-015 Revision D GE, Recall # Z-1132-2007;
b) GE Medical Systems CardioLab System, electrophysiological data system,
    Software Version 6.5 2021423-016 Revision D GE, Recall # Z-1133-2007;
c) GE Healthcare Systems ComboLab System. Made up of both Mac-Lab System,
    Software Version 6.5 2021423-015 Revision D and CardioLab System,
    Software Version 6.5 2021423-016 Revision D. Electrophysiological data systems,
    Recall # Z-1134-2007
CODE
a) Serial Number: SBT05460156GA SBT05460162GA SBT05460163GA AA505242210GA SBT06511750GA
    2003 acq1 2003 acq2 AA504130408FA SBT06120684GA AA505242190GA AA504300892GA
    SBT05520430GA SBT05520431GA SBT05520432GA SBT05520433GA SBT06341246GA
    AA504391102GA AA505091801GA AA504110305FA SBT05440090GA SBT05470225GA
    SBT05480245GA AA504451274GA AA504451275GA AA504451276GA SBT06100629GA
    SBT06230966GA SBT06100626GA SBT06100627GA SBT06110661GA SBT06311146GA
    AA505322445GA SBT06491674GA SBT06501680GA AA504210563FA AA504210564FA
    AA504210565FA AA504210562FA AA505212125GA AA505342501GA AA505242213GA
    SBT05500362GA SBT06331210GA SBT06511743GA SBT06511730GA SBT06451560GA
    SBT06401398GA SBT06401418GA SBT05500378GA SBT05480241GA SBT05480244GA
    SBT06501688GA SBT06331187GA SBT06311166GA SBT06311167GA SBT06331213GA
    SBT06341216GA SBT06341217GA SBT06341215GA SBT05500390GA SBT05500389GA
    AA504150487FA SBT06481627GA AA505232177GA AA505222144GA AA505242217GA
    AA505252219GA AA505141929GA AA505091803GA AA505161970GA SBT06371293GA
    SBT07021831GA SBT07021830GA AA504240694GA AA504280854GA AA504531544GA
    AA504361066GA SBT06190820GA SBT06190823GA AA505101827GA SBT05500393GA
    SBT06190829GA SBT05430065GA SBT06020452GA AA504110303FA AA504110304FA
    AA504120333FA AA504120334FA AA504120335FA AA504120336FA AA504120337FA
    AA504130433FA AA505372563GA AA504240693GA AA504130405FA AA504130407FA
    SBT06401390GA SBT06401419GA AA505091794GA AA505091792GA AA505091807GA
    AA505101816GA SBT06441536GA SBT06441537GA SBT06441540GA 2003 acq-tbd
    2003 acq-tbd AA505111846GA AA505081716GA SBT06511732GA 2003 acq-tbd
    AA505342490GA AA505081735GA SBT06481611GA AA505342510GA AA505322402GA
    AA504250706GA AA504351024GA AA504110293FA AA505332482GA SBT06511733GA
    SBT06150737GA SBT05450128GA SBT05450146GA SBT05450151GA SBT05460152GA
    SBT06501693GA AA504200526FA AA504200527FA SBT07061898GA SBT07061899GA
    SBT05500408GA SBT06160772GA SBT06020466GA SBT05480271GA AA505262257GA
    AA505262258GA SBT06060578GA AA505322446GA SBT06150745GA SBT06230965GA
    SBT06240981GA SBT06190819GA SBT06371293GA SBT06511745GA SBT06501715GA
    AA505332479GA AA505342496GA AA505342497GA AA505342505GA AA505422646GA
    SBT06371308GA SBT06371318GA SBT05460179GA AA504441241GA AA504441257GA
    AA505081769GA SBT06220947GA AA505212115GA AA505232155GA AA505232159GA
    AA505372575GA SBT06501710GA SBT06511734GA SBT06511736GA AA505302383GA
    AA505372597GA AA504521483GA AA504020173FA AA504020174FA AA505332458GA
    AA505332469GA AA505342491GA SBT05480251GA SBT05480266GA SBT06291080GA
    SBT06291090GA AA504240702GA AA505081721GA AA505081725GA SBT05480264GA
    SBT06381351GA AA504200529FA AA505151940GA AA505332456GA AA505332457GA
    AA505332466GA AA505071691GA AA504120315FA AA504120316FA AA505322408GA
    SBT06110650GA SBT06110659GA SBT06110674GA AA505372572GA AA505372573GA
    AA505372577GA AA505282288GA AA505282290GA SBT06491663GA AA504280859GA
    AA504280860GA SBT06150732GA AA504070242FA SBT06230961GA SBT06251016GA
    AA505081773GA AA505081775GA AA505081777GA AA504220599FA AA504220609FA
    AA504220606FA AA504220605FA AA504220608FA AA504220610FA AA504220607FA
    SBT06491672GA 2003 acq1 2003 acq2 2003 acq3 AA504351027GA SBT06451559GA
    SBT06451554GA AA504391090GA AA505071659GA SBT06251034GA AA505212132GA
    AA505372618GA SBT06481634GA SBT06381346GA AA505161989GA AA505172000GA
    AA505192057GA AA505312397GA AA505312399GA SBT06180794GA AA504391104GA
    AA504391105GA AA504391107GA AA504391088GA AA504451269GA AA504491390GA
    AA504421200GA AA504491389GA AA504531548GA AA505021596GA AA505031628GA
    AA505292320GA AA505292321GA AA505292324GA AA504361064GA AA504361070GA
    SBT06070593GA SBT06421462GA SBT06421461GA AA504351058GA AA504451278GA
    AA504340982GA AA504391095GA AA504391096GA SBT06020479GA SBT06020484GA
    AA505151958GA AA504130432FA SBT06180791GA AA505091797GA AA504351045GA
    AA504351050GA SBT05500363GA AA504330966GA SBT06220944GA SBT06230967GA
    SBT06230970GA SBT06230971GA SBT06230974GA SBT06331209GA AA504391113GA
    SBT05430054GA SBT05500403GA AA505172002GA SBT06511748GA SBT06281063GA
    SBT06281070GA SBT06291079GA SBT05450116GA SBT05470223GA AA504451282GA
    AA504451283GA AA504180515FA AA504431209GA AA504431210GA AA504431211GA
    AA505312398GA AA505362536GA SBT05440098GA SBT05450123GA SBT05460172GA
    SBT05440099GA SBT06060576GA AA504451281GA AA505222143GA AA504391117GA
    AA504240685GA AA504240686GA AA505452664GA AA505302376GA AA505302353GA
    AA505302356GA AA505302377GA AA505302378GA SBT06511731GA SBT06511747GA
    SBT06180805GA AA505242187GA AA504531541GA AA504531542GA SBT06251002GA
    AA505222145GA SBT06391364GA AA505031614GA SBT06050551GA AA505141925GA
    SBT06501720GA SBT06501721GA SBT06451556GA AA505081758GA AA505081759GA
    AA504110306FA AA505091798GA SBT06491669GA SBT06491675GA AA504260758GA
    AA505081772GA AA505081784GA AA504020166FA 2003 acq-tbd SBT06481609GA
    SBT06100620GA SBT06100631GA SBT06120687GA SBT06251039GA AA505322447GA
    SBT06150753GA AA504531545GA AA504180515FA AA504210546FA AA504210547FA
    SBT05460176GA SBT05440091GA SBT05440092GA SBT05430064GA AA504120348FA 2003 acq-tbd
    AA505081781GA AA505141936GA AA505141937GA SBT06251013GA SBT06190828GA
    AA505292323GA SBT06120685GA AA504280857GA SBT06291083GA AA504451284GA
    AA504531524GA AA505322414GA AA504411154GA AA504250715GA SBT06040524GA
    AA504401123GA AA504411162GA AA504401122GA AA504411161GA AA504421199GA
    AA505151960GA AA505171995GA AA505202092GA AA504250707GA AA504330960GA
    SBT05440107GA SBT05470233GA SBT05470234GA AA505011568GA AA505292313GA
    2003 acq1 2003 acq2 2003 acq3 SBT06060582GA 2003 acq1 2003 acq2 2003 acq3 2003 acq4
    SBT06501704GA SBT05480261GA SBT05480262GA SBT05340007GA SBT05350029GA
    SBT05350030GA AA504501425GA AA504501432GA AA504501433GA AA504501429GA
    AA505322412GA AA505292309GA AA505292310GA AA505292311GA AA505282283GA
    SBT06331183GA SBT06331201GA AA504340999GA SBT06281046GA SBT06331208GA
    AA504140463FA SBT06220935GA SBT06371284GA AA504210550FA SBT06371278GA
    AA504391080GA AA504391081GA AA504140465FA AA505262238GA AA505262240GA
    AA505332475GA SBT05500404GA SBT05450124GA SBT05450125GA SBT05450129GA
    SBT05450130GA SBT05460154GA SBT05460160GA SBT05470226GA SBT05470232GA
    AA505192060GA AA505222142GA AA504481355GA AA504481356GA AA504481357GA
    AA504260802GA AA505141912GA SBT06381343GA AA505192048GA AA505242194GA
    AA505262237GA AA505262241GA AA505342508GA SBT06401399GA SBT05440088GA
    SBT05440096GA SBT05440106GA AA505081738GA AA505081739GA AA505081744GA  
    AA505081745GA SBT05500380GA SBT05460168GA SBT06401386GA AA504260796GA
    AA504260775GA AA504260774GA AA504260777GA AA504260797GA AA505212117GA
    AA504391108GA AA505242196GA AA505282292GA AA504411140GA AA504441255GA
    SBT06070602GA SBT06100609GA SBT06501712GA SBT06511724GA SBT06511735GA
    SBT06501700GA AA505021578GA SBT07021833GA AA504330965GA AA505202088GA
    AA504471345GA AA504471346GA AA504471318GA AA505091800GA AA504130435FA
    AA504130436FA AA504130439FA AA504130437FA AA504130441FA AA504130442FA
    AA505071694GA AA505071715GA AA505071688GA AA505071698GA SBT06160763GA
    AA504260740GA AA504260742GA AA504260743GA AA504260741GA AA504240694GA
    AA505362540GA SBT05430063GA SBT06160761GA SBT07051885GA SBT07051886GA
    SBT07051889GA SBT06010434GA AA504120338FA AA504120339FA AA504120340FA
    AA504260745GA AA504260746GA SBT06140711GA SBT06281065GA SBT07041865GA
    SBT07041867GA SBT07041870GA AA505282282GA AA504501416GA AA505222144GA
    AA505322448GA SBT06140713GA SBT05500381GA AA505111850GA AA505111856GA
    AA505111857GA AA504110290FA AA504130350FA SBT06301134GA AA505081764GA
    AA505081766GA AA505081770GA SBT05480242GA AA505011569GA SBT06371307GA
    SBT05440103GA AA504180510FA AA504180511FA AA504180512FA SBT06311145GA
    AA504521478GA AA504521479GA AA504411163GA AA504340992GA SBT06251003GA
    SBT06251007GA SBT06251008GA AA504110302FA AA505342518GA AA505232171GA
    AA505232167GA AA505232168GA AA505232172GA AA505161988GA SBT06251004GA
    SBT06251012GA AA504491383GA SBT05480279GA SBT05500382GA AA505212113GA
    AA505292307GA AA505292312GA AA505292319GA AA505242200GA SBT06050555GA
    SBT06040529GA SBT06050554GA SBT06110639GA SBT06100611GA SBT06100633GA
    SBT06110636GA AA505292317GA AA505292318GA AA504471317GA AA505282291GA
    AA505262254GA AA505262255GA SBT06120682GA AA504250718GA AA504250720GA
    AA504250722GA AA504250723GA AA504250721GA SBT05430068GA SBT05430071GA
    SBT06100607GA AA505212120GA AA504070243FA AA504070244FA AA504070249FA
    AA505322419GA AA504120307FA AA504120308FA AA504401131GA AA504140483FA
    AA505091795GA AA504260764GA AA504260765GA AA504260766GA AA504250726GA
    SBT05500385GA SBT05500399GA SBT05500400GA SBT06501685GA SBT06501687GA
    SBT06511727GA SBT06160773GA AA504531528GA AA504531529GA AA504451277GA
    AA505242193GA SBT06281052GA SBT06110642GA AA504411166GA SBT06251021GA
    SBT06240986GA SBT06251016GA SBT06381327GA SBT06331207GA AA504300894GA
    BetaSSNtbd BetaSSNtbd BetaSSNtbd BetaSSNtbd BetaSSNtbd BetaSSNtbd BetaSSNtbd
    SBT05480254GA SBT06240987GA SBT06240990GA AA504030200FA AA504030201FA
    AA504030202FA SBT06401420GA SBT05500407GA SBT06501705GA AA504461294GA
    AA504471329GA AA504471318GA AA504330978GA AA504340990GA AA504340994GA
    AA505222141GA SBT05500370GA SBT05500410GA SBT05500411GA SBT05500417GA
    SBT05500419GA SBT05500421GA SBT05500386GA SBT05500402GA SBT05500409GA
    SBT06040526GA SBT06060565GA SBT05460157GA SBT05460158GA SBT07051893GA
    SBT06511733GA AA505332470GA SBT06180808GA SBT06180812GA SBT06190814GA
    SBT06110644GA SBT06110662GA AA505212108GA SBT06461579GA SBT06461580GA
    SBT06461581GA SBT06281042GA AA505081741GA SBT06020469GA SBT06020467GA
    SBT05450118GA SBT05450131GA SBT06020474GA AA505161982GA AA505182022GA
    AA504210577FA AA504210578FA AA504471348GA AA504471349GA AA504471350GA
    SBT06501716GA AA505141931GA AA505212102GA AA505212101GA AA505212103GA
    AA505141930GA AA505141935GA AA505372562GA SBT06501708GA SBT06501714GA
    AA504240699GA AA504240700GA AA504240701GA SBT06281075GA SBT05460171GA
    SBT05460178GA AA505332477GA AA505372616GA SBT06501718GA AA504501431GA
    SBT06150751GA SBT06160757GA SBT06180806GA SBT06220932GA AA505372583GA
    AA505372579GA AA505372581GA AA505372586GA SBT05500375GA SBT05500388GA
    SBT05500397GA SBT06301137GA AA505362538GA AA505342512GA AA504260800GA
    AA504130431FA AA504130434FA AA504130446FA AA504260763GA AA504341004GA
    AA504120309FA SBT06020482GA SBT06020483GA SBT06070590GA SBT06070592GA
    SBT06070596GA AA505182028GA AA505212100GA SBT06501703GA SBT06501711GA
    AA504260753GA SBT06281071GA SBT06281074GA SBT05440089GA 2003 acq-tbd
    2003 acq-tbd SBT06481644GA AA505172014GA AA504030199FA AA505452658GA
    SBT06020464GA SBT06371277GA AA505081780GA AA504421195GA AA504300895GA
    AA504290875GA AA505332462GA 2003 acq1 2003 acq2 2003 acq3 SBT05460159GA
    AA505091803GA AA505161970GA AA505332480GA SBT06491652GA SBT06491655GA
    SBT06281076GA SBT06281078GA SBT06331189GA SBT06501686GA SBT06511728GA
    SBT06511742GA AA504120346FA AA504120345FA AA504130353FA AA504130354FA
    AA504491374GA AA503510088FA AA504030191FA AA504030192FA AA504030193FA
    SBT06190819GA AA505081768GA AA505101840GA AA505101841GA AA505101842GA
    AA505101843GA AA504280864GA AA504280865GA AA505131903GA AA505131906GA
    2003 acq-tbd 2003 acq-tbd AA504120311FA AA504521480GA AA504521481GA
    AA504130398FA AA504130399FA AA504130400FA AA504130401FA AA504130402FA
    AA504130403FA SBT05480273GA AA504140466FA AA504140467FA AA504140468FA
    AA504140469FA AA504140470FA AA504020186FA AA504020187FA AA504020188FA
    AA505302368GA AA505302369GA AA505101829GA SBT06371314GA AA504411164GA
    AA504411168GA SBT05460170GA SBT06251019GA SBT06491654GA SBT06491659GA
    SBT06491657GA SBT06491664GA SBT06491668GA AA505372582GA AA505242189GA
    AA505151946GA AA505151947GA AA505151957GA AA505151964GA AA504471312GA
    SBT06501694GA AA504491385GA AA505081723GA AA504351020GA AA504290873GA
    AA504290876GA 2003 acq1 2003 acq2 2003 acq3 2003 acq4 AA504391087GA SBT05470219GA
    SBT06160764GA SBT06160765GA AA505011567GA AA505021585GA AA504491375GA
    AA505372570GA AA505372580GA AA505171997GA AA505172001GA AA505172003GA
    AA505242214GA SBT06160771GA SBT06301132GA SBT06301141GA AA504130428FA
    2003 acq-tbd AA504260757GA SBT06150752GA SBT06311171GA SBT06311175GA
    SBT06321176GA SBT06371315GA SBT06381324GA SBT06381328GA SBT06381345GA
    SBT06381348GA AA504020167FA AA504020168FA AA504020171FA SBT06251017GA
    SBT06251025GA SBT06180801GA SBT06190813GA SBT06190815GA SBT06180803GA
    SBT06190818GA SBT06190816GA SBT06331205GA SBT06331206GA AA505322406GA
    AA505322409GA SBT06511749GA SBT06511752GA SBT06511756GA AA504180519FA
    AA505081717GA SBT05430067GA SBT05430072GA SBT05480243GA AA505192055GA
    AA504351051GA AA504351056GA AA505362530GA AA504130351FA SBT06060579GA
    SBT06070605GA SBT06120704GA SBT06120686GA AA505011573GA AA505081732GA
    AA505081733GA AA505081767GA AA504260748GA AA504260749GA AA504260750GA
    AA504260751GA AA505312395GA AA505342494GA SBT06100606GA AA505031617GA
    AA505081717GA SBT06150744GA AA505071656GA AA505071657GA AA505071660GA
    AA504491382GA SBT06301125GA SBT06371304GA SBT06371320GA SBT06381323GA
    SBT06301125GA AA505151959GA AA504330974GA AA504330975GA AA504330976GA
    AA504330979GA AA504330980GA AA504481354GA SBT06010445GA AA504310911GA
    AA504310913GA SBT07041866GA AA505212126GA AA505081761GA SBT06301121GA
    AA504120338FA AA504120339FA AA504120340FA AA504140472FA AA505372610GA
    AA505081726GA AA505081728GA AA505081729GA AA505081727GA SBT06411427GA
    AA504210572FA AA504210573FA AA504210574FA AA504120319FA AA504120320FA
    AA504120321FA AA504120322FA SBT05460164GA SBT06281056GA SBT06251040GA
    SBT06281054GA AA504120324FA AA504120323FA AA504501428GA AA504260767GA
    AA504260768GA AA504260769GA AA504260770GA SBT06281072GA SBT06281045GA
    SBT06281055GA AA504340993GA SBT05500395GA SBT05500387GA SBT06100613GA
    AA505322439GA SBT06381341GA SBT06010447GA SBT06451558GA AA505011562GA
    AA504441253GA AA504451272GA SBT06371289GA SBT06481636GA AA504280850GA
    SBT06421460GA AA505091803GA SBT06281051GA SBT06281053GA AA505422644GA
    AA504300906GA SBT06491650GA SBT06371276GA SBT06341218GA AA505111870GA
    AA505302355GA AA504411173GA AA504411175GA SBT06431498GA AA504451280GA
    AA504451279GA SBT07051891GA SBT06170780GA SBT06170782GA AA505242197GA
    AA505282294GA AA505292315GA AA505362529GA SBT05450120GA SBT06371294GA
    SBT06100619GA AA504130438FA AA504130440FA AA505161985GA AA505161986GA
    AA505161983GA AA505161984GA SBT06020472GA AA504421187GA AA504340995GA
    AA504401124GA AA504401125GA AA504401126GA AA504401130GA AA504401132GA
    AA504401134GA AA504401135GA AA504441240GA AA504461293GA SBT05430052GA
    AA504521485GA AA505101844GA AA505101845GA AA505111847GA AA504491378GA
    AA504491379GA AA504491380GA AA504391088GA AA504391104GA AA504391105GA
    AA504501423GA AA505021594GA AA505021595GA AA505071662GA AA505071664GA
    AA505111851GA SBT06240989GA SBT06230969GA AA504100285FA AA504100286FA
    SBT06251015GA SBT06251026GA AA504531531GA AA504531532GA AA504531533GA
    SBT06511757GA SBT07021823GA SBT07031847GA SBT07041856GA AA504260756GA
    SBT05500418GA SBT06060581GA SBT07061897GA AA505242186GA SBT06251023GA
    SBT06251029GA SBT06100622GA SBT06100628GA AA504230682GA AA505071661GA
    AA505322407GA SBT06371297GA SBT06381330GA SBT06160776GA SBT06230959GA
    AA505141909GA SBT06491648GA SBT06491656GA SBT06491662GA SBT06501702GA
    AA505071693GA AA504070229FA AA504100278FA AA504100280FA AA504100281FA
    AA504100282FA AA504110287FA AA504120332FA AA504130349FA AA504150486FA
    AA504160491FA AA504160496FA AA504160497FA AA504170499FA AA504180520FA
    AA504210555FA AA504210556FA AA504210569FA AA504220625FA AA504220662GA
    AA504240687GA AA504240688GA AA504240703GA AA504250732GA AA504250733GA
    AA504250736GA AA504260747GA AA504280848GA AA504280849GA AA504280851GA
    AA504280853GA AA504290866GA AA504290867GA AA504290869GA AA504300890GA
    AA504300892GA AA504330963GA AA504341001GA AA504341002GA AA504341003GA
    AA504341007GA AA504341008GA AA504341009GA AA504351022GA AA504351026GA
    AA504351029GA AA504351034GA AA504351047GA AA504351052GA AA504351053GA
    AA504351054GA AA504381079GA AA504391103GA AA504401120GA AA504401121GA
    AA504401136GA AA504411169GA AA504411170GA AA504411174GA AA504421196GA
    AA504421201GA AA504421202GA AA504421207GA AA504441237GA AA504441238GA
    AA504441242GA AA504441260GA AA504441263GA AA504441267GA AA504451270GA
    AA504451273GA AA504461295GA AA504471302GA AA504471306GA AA504471311GA
    AA504471316GA AA504471318GA AA504471323GA AA504471330GA AA504471347GA
    AA504491367GA AA504491371GA AA504491393GA AA504491395GA AA504491396GA
    AA504501415GA AA504501418GA AA504501420GA AA504501426GA AA504501430GA
    AA504521487GA AA504531522GA AA505011561GA AA505011564GA AA505021574GA
    AA505021579GA AA505021584GA AA505021597GA AA505031615GA AA505031634GA
    AA505041642GA AA505041643GA AA505041645GA AA505071655GA AA505071663GA
    AA505071665GA AA505071666GA AA505071667GA AA505071685GA AA505071696GA
    AA505071705GA AA505081720GA AA505081736GA AA505081746GA AA505081762GA
    AA505081765GA AA505081778GA AA505081783GA AA505091790GA AA505091804GA
    AA505101818GA AA505101826GA AA505111860GA AA505111868GA AA505141909GA
    AA505141934GA AA505151941GA AA505151955GA AA505151962GA AA505161968GA
    AA505171994GA AA505171998GA AA505171999GA AA505192053GA AA505192054GA
    AA505192058GA AA505192075GA AA505202086GA AA505202093GA AA505202096GA
    AA505202098GA AA505212104GA AA505212109GA AA505212112GA AA505232163GA
    AA505232173GA AA505232176GA AA505242184GA AA505242188GA AA505242195GA
    AA505242201GA AA505242205GA AA505242208GA AA505242210GA AA505242211GA
    AA505242212GA AA505282266GA AA505282274GA AA505282288GA AA505282290GA
    AA505282293GA AA505302350GA AA505302351GA AA505302359GA AA505302360GA
    AA505302382GA AA505312392GA AA505322410GA AA505322411GA AA505322416GA
    AA505322436GA AA505322437GA AA505322440GA AA505322450GA AA505332467GA
    AA505332483GA AA505342488GA AA505342492GA AA505342493GA AA505342499GA
    AA505342502GA AA505342509GA AA505362523GA AA505362528GA AA505362533GA
    AA505362535GA AA505372564GA AA505372565GA AA505372566GA AA505372567GA
    AA505372568GA AA505372591GA AA505372611GA AA505372612GA AA505372614GA
    AA505372615GA AA505422648GA AA505442656GA AA505452659GA AA505452662GA
    AA505452663GA AA505462665GA AA505462666GA AA505462671GA AA505462677GA
    AA505482687GA AA505482688GA AA505482695GA AA505512698GA AA505512701GA
    AA505512702GA AA505512703GA AA505522706GA AA505522707GA AA506022716GA
    AA506042722GA AA506052723GA AA506082725GA AA506082727GA RST07039958GA
    SBT05430051GA SBT05430055GA SBT05430058GA SBT05430066GA SBT05430069GA
    SBT05440097GA SBT05440104GA SBT05450111GA SBT05450113GA SBT05450117GA
    SBT05450127GA SBT05450132GA SBT05450133GA SBT05450142GA SBT05450143GA
    SBT05450149GA SBT05460182GA SBT05470217GA SBT05470224GA SBT05470230GA
    SBT05480239GA SBT05480246GA SBT05480249GA SBT05480252GA SBT05480253GA
   SBT05480256GA SBT05480259GA SBT05480269GA SBT05480274GA SBT05480275GA
    SBT05480276GA SBT05480277GA SBT05480278GA SBT05490323GA SBT05500366GA
    SBT05500368GA SBT05500373GA SBT05500374GA SBT05500383GA SBT05500412GA
    SBT06010435GA SBT06010436GA SBT06010437GA SBT06010438GA SBT06010444GA
    SBT06020450GA SBT06020480GA SBT06020485GA SBT06030505GA SBT06040528GA
    SBT06040529GA SBT06050553GA SBT06050554GA SBT06050555GA SBT06050559GA
    SBT06050561GA SBT06060564GA SBT06070588GA SBT06070589GA SBT06070595GA
    SBT06070597GA SBT06070601GA SBT06100612GA SBT06100614GA SBT06100616GA
    SBT06100630GA SBT06110637GA SBT06110647GA SBT06110655GA SBT06110663GA
    SBT06110666GA SBT06120683GA SBT06120702GA SBT06120703GA SBT06140708GA
    SBT06140710GA SBT06140712GA SBT06140719GA SBT06140726GA SBT06140727GA
    SBT06140728GA SBT06150733GA SBT06150736GA SBT06150741GA SBT06150742GA
    SBT06150754GA SBT06150756GA SBT06160777GA SBT06180784GA SBT06180792GA
    SBT06180793GA SBT06180796GA SBT06180800GA SBT06190827GA SBT06190830GA
    SBT06190832GA SBT06220931GA SBT06220933GA SBT06220936GA SBT06220946GA
    SBT06230961GA SBT06230973GA SBT06240986GA SBT06251006GA SBT06251036GA
    SBT06261041GA SBT06281050GA SBT06281077GA SBT06291081GA SBT06291087GA
    SBT06291088GA SBT06301124GA SBT06301126GA SBT06301128GA SBT06301129GA
    SBT06301133GA SBT06301135GA SBT06301138GA SBT06301140GA SBT06301143GA
    SBT06311147GA SBT06331188GA SBT06331190GA SBT06331191GA SBT06331203GA
    SBT06331204GA SBT06341246GA SBT06341248GA SBT06371281GA SBT06371293GA
    SBT06371312GA SBT06371313GA SBT06371322GA SBT06381331GA SBT06381333GA
    SBT06381335GA SBT06381353GA SBT06391375GA SBT06391376GA SBT06401387GA
    SBT06401400GA SBT06411423GA SBT06411428GA SBT06421456GA SBT06421465GA
    SBT06421466GA SBT06431499GA SBT06441523GA SBT06451549GA SBT06451550GA
    SBT06451551GA SBT06451552GA SBT06451555GA SBT06451557GA SBT06451561GA
    SBT06451563GA SBT06461576GA SBT06461577GA SBT06481612GA SBT06481613GA
    SBT06481617GA SBT06481619GA SBT06481623GA SBT06481628GA SBT06481632GA
    SBT06481641GA SBT06481642GA SBT06481643GA SBT06491647GA SBT06491658GA
    SBT06491666GA SBT06491667GA SBT06501690GA SBT06501692GA SBT06501698GA
    SBT06501701GA SBT06501707GA SBT06511723GA SBT06511738GA SBT06511741GA
    SBT06511744GA SBT06511751GA SBT06511755GA SBT06511759GA SBT06521761GA
    SBT07011806GA SBT07021821GA SBT07021826GA SBT07021832GA SBT07041854GA
    SBT07051888GA SBT07051890GA SBT07061896GA SBT07061904GA AA504070263FA
    AA504140481FA AA504150489FA AA504280861GA AA504411152GA AA504461296GA
    AA504471305GA AA504481359GA AA505021598GA AA505041646GA AA505071690GA
    AA505182029GA AA505182030GA AA505182038GA AA505182040GA AA505192047GA
    AA505192049GA AA505192050GA AA505202094GA AA505302352GA AA505302358GA
    A505302361GA AA505302372GA AA505302375GA AA505452657GA SBT06140720GA;

b) Serial Number: AA504130444FA AA504130352FA AA505141920GA AA504471328GA
    SBT06461585GA AA504461288GA SBT06511737GA SBT06110645GA AA505182032GA
    SBT06220927GA AA505322413GA SBT06401392GA SBT05500379GA AA505342520GA
    SBT06381340GA AA504411171GA AA505262243GA AA505111849GA SBT06311173GA
    SBT06311172GA AA505322444GA AA504351048GA AA505342503GA AA504290877GA
    SBT06220945GA SBT06230975GA SBT06421454GA AA504310914GA AA504330959GA
    AA505182031GA SBT06110652GA SBT06451566GA SBT05470229GA SBT06421457GA
    SBT06481624GA SBT06481626GA AA505081737GA AA504110301FA AA504441266GA
    AA505292316GA SBT06381339GA SBT05500367GA SBT06301122GA AA505292316GA
    AA505101814GA SBT05350031GA SBT06291098GA SBT05440093GA SBT05440094GA
    SBT05460167GA AA504471344GA SBT05500376GA AA504351044GA SBT06501689GA
    AA504531547GA SBT06180804GA SBT06331196GA SBT06331193GA AA505222147GA
    AA505302380GA AA505312394GA AA504381076GA AA504381077GA AA504220604FA
    AA504220611FA SBT06511753GA SBT06481629GA SBT06481614GA AA504391114GA
    AA504391115GA AA504531549GA AA504210549FA AA504351049GA AA504421186GA
    AA504391106GA AA505212116GA AA505372589GA SBT06251035GA SBT06230968GA
    AA505021576GA AA505021580GA SBT06301136GA AA504210551FA AA504391116GA
    AA505111866GA SBT06441525GA SBT05450121GA SBT06441529GA SBT06441530GA
    AA505372595GA AA504220626FA SBT06060584GA AA505322403GA SBT06481615GA
    SBT06491671GA SBT05460174GA SBT05480240GA AA504361063GA AA505011570GA
    AA505011571GA AA505011572GA AA504531525GA SBT06401391GA AA505161991GA
    SBT05350026GA SBT05350027GA SBT06381339GA SBT06251005GA AA505111869GA
    AA504260803GA AA505262239GA AA505342500GA AA505242199GA AA505101809GA
    SBT05490318GA SBT06030511GA AA505202090GA AA505121889GA AA504451271GA
    AA504531552GA AA503490073FA AA504030204FA SBT06020463GA AA504401139GA
    AA504381078GA AA505362527GA SBT05430057GA SBT05460173GA AA505372574GA
    AA504300909GA AA505121895GA AA504300896GA SBT05460181GA SBT06050550GA
    SBT06050556GA AA504401138GA AA504361068GA AA504361069GA AA505322418GA
    AA504391097GA AA504391098GA AA504391099GA SBT05500392GA SBT06030504GA
    SBT06070587GA SBT06140722GA AA504110292FA SBT06100621GA AA504010139FA
    SBT06361270GA SBT06391356GA SBT06391357GA SBT06391360GA AA505232156GA
    AA505232157GA AA505232158GA AA505292322GA SBT06381332GA AA504240696GA
    AA504531523GA SBT06251037GA SBT06281066GA SBT06421458GA AA504391112GA
    SBT06251020GA AA504511475GA AA504330969GA AA504491397GA AA504491399GA
    AA504130355FA SBT06070586GA AA504341006GA AA504290878GA SBT06100624GA
    AA505242206GA SBT06451570GA SBT06240988GA 2003 acq-tbd SBT06491661GA
    AA505121897GA AA505212114GA SBT06491665GA SBT06491670GA SBT06491660GA
    SBT06301142GA AA504491377GA AA504471314GA AA504531526GA AA504361062GA
    SBT05500396GA AA504531543GA AA504280855GA SBT06251024GA SBT06110638GA
    SBT06291086GA AA505322449GA AA505332459GA AA505141921GA SBT06381350GA
    SBT05450119GA AA505262245GA AA505302379GA SBT06421455GA SBT06421483GA
    AA505071654GA SBT06331179GA AA504501454GA AA504220665GA AA505192062GA
    AA505192063GA AA504220603FA SBT05470235GA SBT05470236GA SBT06020469GA
    SBT06281067GA AA504290874GA AA504441265GA 2003 acq1 2003 acq2 SBT05480268GA
    SBT05450112GA SBT05450115GA AA505091802GA SBT07041868GA AA505232165GA
    AA505422647GA AA505372578GA AA505041647GA SBT06100632GA SBT06511753GA
    SBT07041855GA SBT07031853GA AA505342506GA SBT06180807GA AA505332464GA
    AA504120318FA AA505242192GA AA504330973GA AA505192052GA AA504351046GA
    SBT06371310GA SBT06220940GA AA505262236GA AA505262242GA AA504411156GA
    AA504120326FA SBT06190837GA AA504140478FA SBT05460175GA AA504110295FA
    SBT05490317GA SBT06501679GA SBT06521789GA SBT06521787GA SBT06521788GA
    AA505081776GA SBT06140716GA SBT06190834GA F4XJ1909F SBT06220928GA
    SBT06220922GA AA504491381GA AA504511474GA SBT06431496GA SBT06431497GA
    SBT06431501GA AA505021575GA SBT05500372GA AA505212110GA SBT06110649GA
    SBT06451568GA SBT06331192GA SBT05450150GA AA505101814GA AA505081779GA
    SBT06371285GA AA504180518FA AA504531536GA AA504531537GA AA505091808GA
    SBT07041871GA AA504491392GA SBT06110658GA 2003 acq-tbd SBT06421482GA
    AA504100283FA AA504110289FA AA504140476FA AA504150488FA AA504150490FA
    AA504160493FA AA504200531FA AA504200532FA AA504210544FA AA504210545FA
    AA504210570FA AA504210575FA AA504220600FA AA504220620FA AA504220661GA
    AA504230684GA AA504240690GA AA504240692GA AA504240704GA AA504250708GA
    AA504250710GA AA504250711GA AA504250712GA AA504250713GA AA504250714GA
    AA504250716GA AA504280855GA AA504280858GA AA504290870GA AA504290879GA
    AA504300893GA AA504300905GA AA504300908GA AA504310910GA AA504320924GA
    AA504320925GA AA504330961GA AA504330962GA AA504330964GA AA504330977GA
    AA504340981GA AA504340996GA AA504351023GA AA504351030GA AA504351032GA
    AA504351057GA AA504361067GA AA504361072GA AA504391082GA AA504391083GA
    AA504391084GA AA504391085GA AA504391101GA AA504391106GA AA504401127GA
    AA504411167GA AA504421198GA AA504421203GA AA504421204GA AA504441239GA
    AA504441256GA AA504471303GA AA504471304GA AA504471325GA AA504471327GA
    AA504471343GA AA504491386GA AA504501422GA AA504501427GA AA504501457GA
    AA504511476GA AA504511477GA AA504521486GA AA505031616GA AA505031626GA
    AA505031629GA AA505031639GA AA505031640GA AA505071684GA AA505071687GA
    AA505081724GA AA505081763GA AA505091805GA AA505091806GA AA505101825GA
    AA505101828GA AA505101837GA AA505111852GA AA505111853GA AA505111854GA
    AA505111858GA AA505111861GA AA505111862GA AA505121882GA AA505121884GA  
    AA505141915GA AA505161967GA AA505161972GA AA505171992GA AA505171996GA
    AA505182020GA AA505182024GA AA505182041GA AA505192059GA AA505192061GA
    AA505202089GA AA505202097GA AA505212105GA AA505212106GA AA505212107GA
    AA505212107GA AA505212123GA AA505242179GA AA505242191GA AA505242198GA
    AA505242207GA AA505242218GA AA505282277GA AA505282284GA AA505292308GA
    AA505302381GA AA505322405GA AA505332485GA AA505332487GA AA505342507GA
    AA505342515GA AA505342516GA AA505342522GA AA505362531GA AA505362532GA
    AA505372592GA AA505372598GA AA505372599GA AA505372602GA AA505372603GA
    AA505372625GA AA505422650GA AA505452660GA AA505452661GA AA505462667GA
    AA505462668GA AA505462669GA AA505462672GA AA505462673GA AA505462675GA
    AA505472680GA AA505472682GA AA505482684GA AA505482686GA AA505482690GA
    AA505482691GA AA505482692GA AA505482697GA AA505512699GA AA505522704GA
    AA505522709GA AA506012712GA AA506012714GA AA506022717GA AA506082730GA
    AA506092731GA AA506102733GA SA705225746GA SBT05430049GA SBT05440108GA
    SBT05440109GA SBT05450148GA SBT05460166GA SBT05460177GA SBT05470218GA
    SBT05470220GA SBT05490321GA SBT05490322GA SBT05500369GA SBT05500413GA
    SBT06010439GA SBT06010442GA SBT06010443GA SBT06020449GA SBT06020458GA
    SBT06020475GA SBT06020477GA SBT06030504GA SBT06050562GA SBT06060563GA
    SBT06060577GA SBT06100608GA SBT06100618GA SBT06110640GA SBT06110653GA
    SBT06110675GA SBT06140709GA SBT06140717GA SBT06140729GA SBT06150747GA
    SBT06160758GA SBT06160759GA SBT06160762GA SBT06160768GA SBT06160774GA
    SBT06170779GA SBT06170781GA SBT06180797GA SBT06180798GA SBT06180809GA
    SBT06190835GA SBT06190836GA SBT06220934GA SBT06220941GA SBT06220942GA
    SBT06230958GA SBT06230962GA SBT06230976GA SBT06240979GA SBT06251022GA
    SBT06281043GA SBT06281061GA SBT06281062GA SBT06281069GA SBT06291093GA
    SBT06291095GA SBT06301123GA SBT06321177GA SBT06331182GA SBT06331184GA
    SBT06331197GA SBT06331198GA SBT06331202GA SBT06341247GA SBT06371280GA
    SBT06371290GA SBT06371291GA SBT06371305GA SBT06371311GA SBT06371321GA
    SBT06381329GA SBT06381334GA SBT06381349GA SBT06391354GA SBT06391355GA
    SBT06401388GA SBT06401389GA SBT06401394GA SBT06401395GA SBT06401397GA
    SBT06401416GA SBT06411431GA SBT06411433GA SBT06421459GA SBT06441527GA
    SBT06441538GA SBT06451553GA SBT06451574GA SBT06461575GA SBT06481610GA
    SBT06481618GA SBT06481620GA SBT06481631GA SBT06481638GA SBT06481639GA
    SBT06481640GA SBT06491646GA SBT06491649GA SBT06491653GA SBT06501676GA
    SBT06501696GA SBT06501713GA SBT06511725GA SBT06511740GA SBT06521760GA
    SBT07011808GA SBT07021822GA SBT07021824GA SBT07021825GA SBT07031835GA
    SBT07031836GA SBT07051883GA SBT07051895GA;
c) Serial Number: AA505282259GA AA505121880GA SBT06391362GA AA504531540GA
    AA504351028GA AA504220601FA AA504220617FA AA504220618FA AA504220619FA
    AA505312391GA AA504351019GA AA504461287GA AA505242216GA SBT06451573GA
    SBT06100634GA SBT06110660GA SBT06110664GA AA504130374FA SBT06511739GA
    AA505262244GA SBT06311169GA SBT05500394GA SBT06481616GA SBT05480257GA
    SBT05500364GA SBT05500371GA SBT05500391GA SBT06421452GA SBT05430053GA
    SBT05430061GA AA505141939GA SBT06411436GA SBT06381342GA SBT06391363GA
    SBT06371317GA SBT06190817GA AA505161990GA AA504130406FA AA504250709GA
    SBT05480263GA SBT05480270GA SBT06331211GA SBT06251018GA AA505081734GA
    AA504401129GA AA504250705GA AA504531538GA SBT06240983GA SBT06251028GA
    SBT06301131GA SBT06381336GA SBT06381338GA SBT06251018GA SBT06501677GA
    SBT06501678GA SBT07011807GA SBT05480238GA SBT05460153GA AA505232162GA
    AA505232169GA AA505232170GA SBT06020481GA SBT06020457GA SBT06251030GA
    AA504260754GA AA504260755GA AA505071692GA SBT06240984GA SBT06401421GA
    SBT06441526GA SBT05460165GA SBT06301130GA AA505372584GA SBT06100615GA
    SBT06481622GA SBT06481630GA SBT06100623GA AA505362539GA SBT05440102GA
    SBT05440105GA SBT06501706GA AA505081731GA SBT06391359GA AA504200528FA
    SBT06371287GA AA505282275GA AA505312389GA SBT06140721GA SBT06110677GA
    AA505372576GA AA505372587GA AA504070228FA AA504070241FA AA504330970GA
    2003 acq1 2003 acq2 SBT06481635GA SBT06481637GA AA505262253GA AA505232154GA
    SBT06120697GA SBT06120699GA SBT06010446GA AA504461289GA AA505031627GA
    SBT06461584GA AA504361065GA AA504391094GA SBT06020470GA AA505071695GA
    AA504421194GA SBT06511729GA SBT05490319GA AA505091793GA AA505332465GA
    SBT06110654GA AA504140482FA SBT05450122GA AA505332484GA AA505141908GA
    AA504210554FA AA504531534GA AA505141922GA SBT06481625GA AA504110294FA
    AA504501455GA 2003 acq-tbd 2003 acq-tbd SBT06441539GA AA504531546GA
    AA504180517FA AA504180516FA AA504210567FA AA504200533FA SBT05430059GA
    AA504260752GA SBT06251014GA SBT06251009GA SBT06251033GA AA504361061GA
    AA504210566FA SBT06281059GA AA504411155GA 2003 acq-tbd SBT06030510GA
    AA504401128GA AA504411143GA AA504411158GA AA504411160GA AA505202091GA
    2003 acq-tbd SBT05480255GA AA505342513GA AA505342514GA SBT06371279GA
    AA505021613GA AA504501414GA AA504411172GA AA505332476GA SBT06220921GA
    SBT06140718GA AA504140477FA AA505141938GA AA505202085GA SBT06020455GA
    AA504461297GA AA504481353GA SBT05480272GA AA504190525FA AA504260801GA
    AA504330967GA AA504330968GA SBT06331195GA SBT06020471GA AA505232161GA
    AA505232166GA SBT06070600GA SBT05500365GA AA504340997GA SBT06070599GA
    SBT06401396GA SBT05440095GA SBT05480247GA SBT05480248GA SBT05480258GA
    SBT05480260GA SBT05440101GA AA504441259GA AA505081742GA AA505081755GA
    SBT06050552GA AA504260776GA AA504260795GA AA504260778GA AA504391111GA
    AA505212122GA AA505081782GA AA505242178GA AA505282289GA AA505121890GA
    AA504411142GA SBT06190825GA AA505202099GA AA505182027GA AA504471319GA
    AA505091799GA AA505071699GA AA505262234GA AA504260744GA SBT05430050GA
    SBT06020453GA AA504230683GA AA504471313GA AA504471322GA AA504481361GA
    SBT06240977GA SBT07041869GA SBT06251032GA SBT06411435GA AA505021581GA
    AA505011566GA AA504180509FA AA505111848GA SBT06220930GA AA504260759GA
    AA505081785GA SBT05470228GA SBT06240985GA AA504411141GA AA505292314GA
    SBT06050552GA AA505262256GA AA504250717GA SBT06441526GA SBT06381336GA
    SBT06381338GA AA504250719GA SBT05430070GA AA504411153GA SBT06120701GA
    AA504120310FA AA504481351GA AA504481352GA SBT06160775GA AA504531527GA
    SBT06501709GA SBT06301139GA AA504160495FA SBT05520429GA SBT06411429GA
    AA504461290GA AA504471324GA AA505522708GA AA505021577GA AA505322438GA
    AA505322415GA SBT05500384GA SBT06060566GA SBT05500420GA AA505202087GA
    AA505192070GA AA505111859GA AA505372571GA AA505332468GA SBT06190821GA
    SBT06461578GA SBT06371298GA AA504481360GA AA504210576FA AA505282278GA
    AA505121896GA AA504471308GA SBT05430060GA SBT05480263GA SBT06381347GA
    SBT06140714GA SBT06150739GA SBT06150748GA SBT06381344GA SBT06251011GA
    SBT06100617GA AA504340991GA AA505192051GA SBT06030502GA AA504341000GA
    AA505182026GA SBT06110656GA AA505151945GA 2003 acq-tbd AA504451285GA
    SBT06311163GA AA505081757GA AA505372585GA SBT06501691GA AA505161969GA
    SBT06281047GA SBT06381352GA SBT06391358GA AA504130356FA AA504120347FA
    AA504030194FA AA504280863GA AA505081743GA AA504130443FA AA504130445FA
    AA504020190FA AA504020189FA AA505021610GA AA505021611GA AA505021612GA
    SBT06281058GA AA504411165GA AA505151963GA AA504471315GA AA504521512GA
    AA504521514GA AA504491373GA AA504290872GA SBT06461582GA AA504120317FA
    SBT07031850GA SBT06511726GA SBT07021827GA SBT07021828GA SBT07031851GA
    AA504130429FA 2003 acq-tbd AA505362558GA AA505141922GA AA505262252GA
    SBT06301127GA SBT06160769GA SBT06160770GA SBT06220937GA AA505192056GA
    SBT05470231GA SBT05480250GA AA505091793GA SBT06190833GA SBT06020465GA
    SBT06040530GA AA504351025GA AA505342504GA AA504411159GA AA504491387GA
    AA504491388GA SBT05500377GA SBT06050557GA AA505212127GA SBT06120698GA
    SBT06190831GA SBT06451569GA AA505121880GA AA504140471FA AA504140473FA
    AA504140474FA AA505061653GA SBT06421453GA AA505081756GA SBT06371316GA
    SBT06110641GA SBT06100635GA SBT06411426GA AA504521513GA SBT05480265GA
    AA504531521GA AA504531535GA AA504531520GA SBT06100610GA AA505141923GA
    AA505342489GA SBT06361268GA AA504441244GA AA504441243GA SBT06371282GA
    SBT06371283GA AA505302374GA AA505302373GA AA505302370GA SBT06411430GA
    AA504341005GA AA505121881GA AA505111864GA AA504140477FA AA505422645GA
    AA504300907GA AA505021582GA AA505372593GA AA505292305GA AA505282276GA
    2003 acq-tbd 2003 acq-tbd AA505031635GA SBT06411424GA AA504521484GA SBT06220923
    GA SBT06240980GA AA504110300FA SBT06441528GA SBT05440100GA SBT05450126GA
    SBT06180788GA SBT06180789GA SBT06180790GA AA504531530GA SBT05460180GA
    SBT06371306GA SBT06070594GA AA505302371GA AA504050209FA AA504070232FA
    AA504070233FA AA504070235FA AA504070236FA AA504070237FA AA504070261FA
    AA504070272FA AA504070273FA AA504080274FA AA504100275FA AA504100276FA
    AA504100277FA AA504100279FA AA504100284FA AA504110288FA AA504120331FA
    AA504120341FA AA504140464FA AA504140475FA AA504140479FA AA504140482FA
    AA504150485FA AA504160492FA AA504160494FA AA504170498FA AA504170500FA
    AA504170501FA AA504180513FA AA504180514FA AA504180517FA AA504180521FA
    AA504190522FA AA504190523FA AA504200530FA AA504200535FA AA504210548FA
    AA504210552FA AA504210553FA AA504210568FA AA504210571FA AA504220602FA
    AA504220621FA AA504220622FA AA504220623FA AA504220624FA AA504220646GA
    AA504220659GA AA504220660GA AA504220663GA AA504220664GA AA504240689GA
    AA504240691GA AA504240695GA AA504240697GA AA504240698GA AA504250724GA
    AA504250725GA AA504250727GA AA504250728GA AA504250734GA AA504250738GA
    AA504260739GA AA504280852GA AA504280856GA AA504280862GA AA504290868GA
    AA504290871GA AA504300889GA AA504300891GA AA504310912GA AA504330971GA
    AA504330972GA AA504340998GA AA504351021GA AA504351031GA AA504351033GA
    AA504351055GA AA504351059GA AA504361071GA AA504361073GA AA504391086GA
    AA504391089GA AA504391100GA AA504391109GA AA504391110GA AA504401118GA
    AA504401119GA AA504401133GA AA504421193GA AA504421197GA AA504421205GA
    AA504421206GA AA504431208GA AA504441254GA AA504441258GA AA504441261GA
    AA504441262GA AA504441264GA AA504441268GA AA504461286GA AA504461291GA
    AA504461292GA AA504461298GA AA504471300GA AA504471301GA AA504471307GA
    AA504471309GA AA504471310GA AA504471321GA AA504471326GA AA504481358GA
    AA504491365GA AA504491366GA AA504491368GA AA504491369GA AA504491370GA
    AA504491372GA AA504491376GA AA504491384GA AA504491391GA AA504491398GA
    AA504501417GA AA504501419GA AA504501421GA AA504501424GA AA504501456GA
    AA504521482GA AA504531540GA AA505011560GA AA505011563GA AA505021583GA
    AA505021599GA AA505021600GA AA505031618GA AA505031636GA AA505031637GA
    AA505031641GA AA505041644GA AA505071658GA AA505071686GA AA505071697GA
    AA505081718GA AA505081719GA AA505081722GA AA505081730GA AA505081740GA
    AA505081760GA AA505081771GA AA505081774GA AA505091791GA AA505101815GA
    AA505101817GA AA505101836GA AA505111863GA AA505121883GA AA505131904GA
    AA505131905GA AA505141907GA AA505141913GA AA505141914GA AA505141924GA
    AA505151956GA AA505151961GA AA505161966GA AA505161969GA AA505161971GA
    AA505161987GA AA505172013GA AA505182025GA AA505182037GA AA505182039GA
    AA505202095GA AA505212111GA AA505212118GA AA505212119GA AA505212121GA
    AA505212124GA AA505222140GA AA505232164GA AA505232174GA AA505232175GA
    AA505242185GA AA505242202GA AA505242209GA AA505242215GA AA505262235GA
    AA505282267GA AA505282285GA AA505282286GA AA505282287GA AA505292306GA
    AA505302349GA AA505302354GA AA505312390GA AA505312396GA AA505312400GA
    AA505322404GA AA505322417GA AA505332460GA AA505332461GA AA505332463GA
    AA505332476GA AA505332478GA AA505332481GA AA505332486GA AA505342495GA
    AA505342498GA AA505342511GA AA505342517GA AA505342519GA AA505342521GA
    AA505362524GA AA505362525GA AA505362526GA AA505362534GA AA505362537GA
    AA505362560GA AA505362561GA AA505372569GA AA505372588GA AA505372590GA
    AA505372594GA AA505372596GA AA505372600GA AA505372601GA AA505372604GA
    AA505372605GA AA505372606GA AA505372609GA AA505372613GA AA505372617GA
    AA505422649GA AA505462670GA AA505462674GA AA505462676GA AA505462678GA
    AA505472679GA AA505472683GA AA505482685GA AA505482689GA AA505482693GA
    AA505512700GA AA505522705GA AA506012710GA AA506012711GA AA506012713GA
    AA506032718GA AA506082726GA AA506082728GA AA506082729GA AA506102732GA
    AA506102734GA AA506102735GA AA506102736GA AA506102737GA AA506102738GA
    K5XJ2445F RST05461052GA RXJ06190181GA SBT05350028GA SBT05430047GA
    SBT05430062GA SBT05440110GA SBT05450114GA SBT05450144GA SBT05450145GA
    SBT05450147GA SBT05460155GA SBT05470221GA SBT05470222GA SBT05480237GA
    SBT05480267GA SBT05480270GA SBT05490320GA SBT05500398GA SBT05500401GA
    SBT05500405GA SBT05500406GA SBT05500416GA SBT06010440GA SBT06020451GA
    SBT06020468GA SBT06020476GA SBT06020478GA SBT06030503GA SBT06030506GA
    SBT06040525GA SBT06050558GA SBT06050560GA SBT06060580GA SBT06060583GA
    SBT06060585GA SBT06070591GA SBT06070598GA SBT06070603GA SBT06070604GA
    SBT06100625GA SBT06110646GA SBT06110657GA SBT06110665GA SBT06110676GA
    SBT06120681GA SBT06120700GA SBT06140706GA SBT06140707GA SBT06140715GA
    SBT06140723GA SBT06140724GA SBT06140725GA SBT06140730GA SBT06150734GA
    SBT06150735GA SBT06150740GA SBT06150743GA SBT06150746GA SBT06150749GA
    SBT06150750GA SBT06150755GA SBT06160760GA SBT06160766GA SBT06160778GA
    SBT06180783GA SBT06180785GA SBT06180786GA SBT06180787GA SBT06180795GA
    SBT06180802GA SBT06180810GA SBT06180811GA SBT06190826GA SBT06220929GA
    SBT06220938GA SBT06220939GA SBT06220943GA SBT06230963GA SBT06230972GA
    SBT06240982GA SBT06240984GA SBT06251001GA SBT06251027GA SBT06251031GA
    SBT06251038GA SBT06281044GA SBT06281048GA SBT06281049GA SBT06281064GA
    SBT06281068GA SBT06281073GA SBT06291082GA SBT06291089GA SBT06291094GA
    SBT06291096GA SBT06291097GA SBT06311144GA SBT06311161GA SBT06311162GA
    SBT06311164GA SBT06311165GA SBT06311168GA SBT06311170GA SBT06311174GA
    SBT06331178GA SBT06331180GA SBT06331181GA SBT06331185GA SBT06331186GA
    SBT06331199GA SBT06331200GA SBT06331212GA SBT06341214GA SBT06361269GA
    SBT06371286GA SBT06371288GA SBT06371292GA SBT06371295GA SBT06371296GA
    SBT06371303GA SBT06371309GA SBT06381325GA SBT06381337GA SBT06391361GA
    SBT06401393GA SBT06401417GA SBT06411422GA SBT06411425GA SBT06411432GA
    SBT06411434GA SBT06411436GA SBT06421463GA SBT06421464GA SBT06421467GA
    SBT06431500GA SBT06441524GA SBT06441541GA SBT06451548GA SBT06451562GA
    SBT06451567GA SBT06451571GA SBT06461583GA SBT06481621GA SBT06481633GA
    SBT06491651GA SBT06491673GA SBT06501681GA SBT06501682GA SBT06501683GA
    SBT06501684GA SBT06501699GA SBT06501717GA SBT06501719GA SBT06501722GA
    SBT06511746GA SBT06511758GA SBT07021829GA SBT07031849GA SBT07051894GA
RECALLING FIRM/MANUFACTURER
General Electric Medical Systems Information Technology, Milwaukee, WI, by letters dated February 16, 2007. Firm initiated recall is ongoing.
REASON
GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues are associated with an audio driver, and the use of the application's log and imaging windows.
VOLUME OF PRODUCT IN COMMERCE
2,909 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Sunrise Medical Quickie Power Wheelchairs: Three models -Rhythm, Groove, and Zippy Z-Bop (with Quickie IQ Enhanced Displays), Recall # Z-1163-2007
CODE
Various serial numbers
RECALLING FIRM/MANUFACTURER
Sunrise Medical Inc., Fresno, CA, by telephone and letter on May 1, 2007. Firm initiated recall is ongoing.
REASON
The wire harness connected to the display housing (Quickie IQ Enhanced Displays) may separate and cause sparks from a short circuit.
VOLUME OF PRODUCT IN COMMERCE
229 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200, Recall # Z-1165-2007
CODE
Lot SA 4426
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lifescan Inc., Milpitas, CA, by letter on March 30, 2007.
Manufacturer: Owen Mumfordltd, Oxford, UK. Firm initiated recall is ongoing.
REASON
Lancet tip may not fully retract and cause needle stick and exposure to used lancets.
VOLUME OF PRODUCT IN COMMERCE
632 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tubing - Blue, List #P4291, Recall # Z-1166-2007
CODE
414371, 414372, 414373, 433069, 433070, 453469, 453470, 453471, 488549, 488550, 488551, 488552, 488553, 488554
RECALLING FIRM/MANUFACTURER
Recalling Firm: ICU Medical, Inc., San Clemente, CA, by letter dated September 26, 2006 and January 10, 2007.
Manufacturer: ICU Medical, Vernon, CT. Firm initiated recall is complete.
REASON
The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.
VOLUME OF PRODUCT IN COMMERCE
26,361 units
DISTRIBUTION
VA, OH, TX, CA, and GA
___________________________________
PRODUCT
VITROS® 5,1 FS (Fusion Series) Chemistry System Software Version 2.2.1, only when using VITROS® Chemistry Products THC (Cannabinoids) or AMPH (Amphetamine) Reagents, Cat. No. 680 1375, Recall # Z-1167-2007
CODE
Serial Numbers 34000121 to 34001377
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by e-mail on May 17, 2007 and by letter on May 18, 2007. Firm initiated recall is ongoing.
REASON
Software design. The firm received a customer complaint regarding a qualitative positive THC (Cannabinoids) result obtained from a THC quality control fluid that was known to be negative when using VITROS® Chemistry Products THC Reagent. A second customer complaint was received a month later. OCD's investigation concluded that under specific circumstances, incorrect qualitative results for Cannabinoids (THC) or Amphetamines (AMPH) could occur when using VITROS® Chemistry Products THC or AMPH Reagents.
VOLUME OF PRODUCT IN COMMERCE
Domestic: 604; International 598
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724, Recall #  Z-1168-2007
CODE
Lots U1629501, U1629502 and U1631782
RECALLING FIRM/MANUFACTURER
Cook Urological, Inc., Spencer, IN, by letter dated June 29, 2007. Firm initiated recall is ongoing.
REASON
The radiographic band may detach from the stent and remain in the patient after removal of the stent.
VOLUME OF PRODUCT IN COMMERCE
75 sets
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use, Recall # Z-1169-2007
CODE
Lot codes 34906, 20207, 30307, 30407, 20507, 30607, 20707, and 40707
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hamilton Co., Reno, NV, by letter and e-mail on March 29, 2007.
Manufacturer: Hamilton Bonaduz AG, Bonaduz, Switzerland. Firm initiated recall is ongoing.
REASON
Some product containers may be leaking.
VOLUME OF PRODUCT IN COMMERCE
797 boxes per unit (48 containers per box)
DISTRIBUTION
NJ, WA, TX and France
___________________________________
PRODUCT
a) CELL-DYN 1700 Hematology Analyzer, List Numbers 03H53-01 and 03H53-03, software
    controlled medical device for diagnostic use., and CELL DYN Control Assay Disk,
    List Numbers 01H91-01 and 01H92-01 when used with above CELL DYN 1700,
    Recall # Z-1170-2007
b) Cell-Dyn 1700CS (Closed Sampler) Hematology Analyzer, List Numbers 03H57-01 and
    03H57-03, software controlled medical device for diagnostic use and CELL DYN
    Control Assay Disk, List Numbers 01H91-01 and 01H92-01 when used with above
    CELL DYN 1700, Recall # Z-1171-2007
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letters on May 7 and May 16, 2007. Firm initiated recall is ongoing.  
REASON
Abnormal results may not be "flagged" appropriately because of a software anomaly. (Flags for the Hemoglobin (HGB), MCH and MCHC parameters when the upper assay parameter limit has been exceeded)
VOLUME OF PRODUCT IN COMMERCE
4,197 units
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
Non-AC-powered Patient Lifts for assisting patients when bathing and toileting-sold under names "Bath Helper" is identified as Model SBB10.0, and "Shower Helper" may be identified a Model SBH10.0 or as "Sisus All In One", Recall # Z-1172-2007
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Sisus Corporation, Santa Cruz, CA, by letter on June 8, 2007.
Manufacturer: Trolli King (Holding) Ltd., Pin Hu, Shenzhen, Guangdong, China (Mainland). Firm initiated recall is ongoing.
REASON
Poor welding may cause the device(s) to fail, which may result in the user, falling in the bathroom and/or a lack of assistance with bathing or toileting.
VOLUME OF PRODUCT IN COMMERCE
Approximately 100 devices
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
ABL77 Cal Pack, Model number 944-069, calibration solutions for use with the ABL77 Blood Gas/Electrolyte analyzer,  Recall # Z-1173-2007
CODE
Lot # 17323
RECALLING FIRM/MANUFACTURER
Sendx Medical, Inc., Carlsbad, CA, by e-mail on June 29, 2007. Firm initiated recall is ongoing.
REASON
Error in the Ca 12 calibration value for pC02 recorded in the cal pack barcode for lot 17323. This error will result in falsely elevated pC02 results at the high end of the measuring range.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION
OH, China, Denmark, Latvia, Mexico and Spain
__________________________________
PRODUCT
a) APhL® HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM, Recall # Z-1175-2007;
b) APhL® HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G, Recall # Z-1176-2007;
c) APhL® HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M, Recall # Z-1177-2007
CODE
a), b) and c) Lot # 050723
RECALLING FIRM/MANUFACTURER
Louisville Apl Diagnostics, Inc., Seabrook, TX, by fax on May – June 2005. Firm initiated recall is complete.
REASON
Mislabeing. Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
VOLUME OF PRODUCT IN COMMERCE
99 test kits
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
a) Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with injection
    port and extension set, Part Number 24200. For use with a Ranger warming unit,
    Recall # Z-1183-2007;
b) Arizant Healthcare Ranger Standard Flow Blood/Fluid Warming Disposable Sets with
    injection port and extension set, Part Number 24250. For use with a Ranger warming unit,
    Recall # Z-1184-2007
CODE
a) and b) Lots B4798 through B4803 and Lot E5111
RECALLING FIRM/MANUFACTURER
Arizant Healthcare, Inc., Eden Prairie, MN, by letter dated June 25, 2007. Firm initiated recall is ongoing.
REASON
Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed.
VOLUME OF PRODUCT IN COMMERCE
97,710 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR AUGUST 22, 2007

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