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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 80-General Hospital/Personal Use


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
FR1-0012137-0/1/1 11-Aug-2008 80BRZ 3003279193 Amsino Medical Instrument Co Ltd China
 
224-0360975-7/1/24 04-Aug-2008 80FMI 1282497 Covidien LLC United States
 
T94-0049043-7/1/1 20-Aug-2008 80FNK 3007064646 Ningbo Haichuang International Trad China
 
K51-0064035-5/1/1 11-Aug-2008 80FOS 3002808465 Vygon, S.A. France
 
K51-0064035-5/2/1 11-Aug-2008 80FOS 3002808465 Vygon, S.A. France
 
K51-0064258-3/1/1 11-Aug-2008 80FOS 3002808465 Vygon, S.A. France
 
K51-0064258-3/4/1 11-Aug-2008 80FOS 3002808465 Vygon, S.A. France
 
K51-0064258-3/5/1 11-Aug-2008 80FOS 3002808465 Vygon, S.A. France
 
224-0360975-7/1/12 04-Aug-2008 80FOZ 1000165314 Central Admixture Pharmacy Inc. United States
 
322-2477482-1/1/1 05-Aug-2008 80FOZ 3003355284 Suzhou Hengxiang Import & Export Co., Ltd. China
 
MH9-0069865-4/1/1 29-Aug-2008 80FPL 3003307657 Ningbo David Medical Device Co.,Ltd China
 
FR1-0012158-6/2/1 11-Aug-2008 80FRN 3000247873 Nipro Corporation Japan
 
FR1-0012358-2/3/1 25-Aug-2008 80FRN 3000247873 Nipro Corporation Japan
 
224-0360975-7/1/19 04-Aug-2008 80JOK 1419843 Armstrong Medical Industries Inc. United States
 
224-0360975-7/1/20 04-Aug-2008 80KGX 1000138386 Medline Industries, Inc United States
 
UPS-2058750-5/1/1 13-Aug-2008 80KMI 3005066666 Stewart Medical Canada
 
XXX-0149699-2/1/1 01-Aug-2008 80LDQ 3001319533 UNKNOWN MANUFACTURER IN MEXICO Mexico
 
144-1895416-3/4/1 04-Aug-2008 80LDQ 3006472698 Osiris Inc Canada
 
112-1559657-1/1/1 21-Aug-2008 80LDQ 3004196898 Deer Valley Health Foods Canada
 
BGF-1005126-3/1/1 21-Aug-2008 80LDQ 3006800291 Scio Norge As Norway
 
112-3999837-3/1/2 25-Aug-2008 80LDQ 3007070384 Taylor United States
 
224-0360975-7/1/13 04-Aug-2008 80LHI 1713468 ICU Medical (Utah) Inc. United States
 
UPS-0043304-0/1/12 18-Aug-2008 80LJS 3002468371 Bard Reynosa S.A. De C.V. Mexico
 
UPS-0043304-0/1/13 18-Aug-2008 80LJS 3002468371 Bard Reynosa S.A. De C.V. Mexico
 
UPS-0043306-5/1/10 18-Aug-2008 80LJS 3002468371 Bard Reynosa S.A. De C.V. Mexico
 
UPS-0043306-5/1/14 18-Aug-2008 80LJS 3002468371 Bard Reynosa S.A. De C.V. Mexico
 
224-0360975-7/1/17 04-Aug-2008 80LKB 1000138386 Medline Industries, Inc United States
 
791-5086655-0/1/1 20-Aug-2008 80LYY 3003338735 JDA Plastic Rubber Co. Ltd. China
 
BIP-0013426-4/2/1 28-Aug-2008 80LYY 3000287381 Supermax Sdn Bhd Malaysia
 
BIP-0013426-4/2/2 28-Aug-2008 80LYY 3000287381 Supermax Sdn Bhd Malaysia
 
BIP-0013426-4/2/3 28-Aug-2008 80LYY 3000287381 Supermax Sdn Bhd Malaysia
 
500-3005934-5/1/1 05-Aug-2008 80LYZ 3004617435 Zibo Hengchang Plastic & Rubber Products Co., Ltd. China
 
525-0746764-6/1/1 19-Aug-2008 80LYZ 3005778754 Wei Fang Jiuzhou Gloves Co., Ltd. China
 
MA7-0573786-8/1/2 20-Aug-2008 80LYZ 3005985328 Liv Medica Equipments Pvt. Ltd. India
 
MA7-0573786-8/1/13 20-Aug-2008 80LYZ 3005985328 Liv Medica Equipments Pvt. Ltd. India
 
855-0022039-8/1/1 29-Aug-2008 80LYZ 3004617435 Zibo Hengchang Plastic & Rubber Products Co., Ltd. China
 
224-0360975-7/1/18 04-Aug-2008 80LZC 1000138386 Medline Industries, Inc United States
 
MH9-0069589-0/1/1 29-Aug-2008 80MED 3007029364 Sercon Industria & Comercio De Aparelhos Medico Brazil
 
700-0120511-4/1/1 27-Aug-2008 80MSN 3006995909 Kingfox Enterprises Limited China
 
K51-0064035-5/4/1 11-Aug-2008 80MWV 3002808465 Vygon, S.A. France
 
112-1577726-2/2/1 22-Aug-2008 80MWV 3005825381 Terumo Belgium
 
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