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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
231-9517162-7/1/2 22-Jun-2009 80FMC 3004059946 Elite International, Inc. China
 
231-9517162-7/1/3 22-Jun-2009 80FMC 3004059946 Elite International, Inc. China
 
231-9517162-7/1/4 22-Jun-2009 80FMC 3004059946 Elite International, Inc. China
 
AEK-9870488-1/1/1 01-Jun-2009 80FMF 3007542332 Ets China
 
XXX-0239372-7/1/3 10-Jun-2009 80FMF 3007182490 Ce Chem Pharmaceuticals India
 
XXX-0239763-7/1/13 10-Jun-2009 80FMF 3006305928 Bd Medical Devices United States
 
AEK-9798866-7/3/1 22-Jun-2009 80FMF 3003902955 Terumo (Philippines) Corporation Philippines
 
FR1-0012638-7/1/1 24-Jun-2009 80FMF 3003528643 Shanghai Kindly Enterprise Group Co. China
 
FR1-0012706-2/1/1 26-Jun-2009 80FOZ 3004070915 Hanako Medical Japan
 
BQL-0019396-9/7/1 29-Jun-2009 80KGX 3003991563 Moscow Pharmaceutical Factory Russia
 
CAY-1011257-8/7/1 16-Jun-2009 80KYR 3005290126 Mediprim Korea, Republic Of (South)
 
CAY-1011257-8/8/1 16-Jun-2009 80KYR 3005290126 Mediprim Korea, Republic Of (South)
 
CAY-1011257-8/9/1 16-Jun-2009 80KYR 3005290126 Mediprim Korea, Republic Of (South)
 
EQ6-0009482-3/1/1 05-Jun-2009 80LDQ 5833 EPPENDORF AG Germany
 
ACN-4000140-4/1/1 08-Jun-2009 80LDQ 3007153839 Guangzhou Sange Electronic Co., Ltd China
 
EQ6-0009481-5/1/1 12-Jun-2009 80LDQ 5833 EPPENDORF AG Germany
 
EQ6-0009516-8/1/1 16-Jun-2009 80LDQ 3006482952 Hologic N.V. Belgium
 
EQ6-0009518-4/1/1 16-Jun-2009 80LDQ 3007217114 Surgical Art S L Spain
 
EQ6-0009561-4/1/1 22-Jun-2009 80LDQ 3005687885 Medin As Czech Republic
 
315-7322976-7/3/1 04-Jun-2009 80LYY 3002806371 Ansell (Ambi) Sdn Bhd Malaysia
 
315-7322976-7/2/1 04-Jun-2009 80LYY 3002806371 Ansell (Ambi) Sdn Bhd Malaysia
 
315-7322976-7/1/1 04-Jun-2009 80LYY 3002806371 Ansell (Ambi) Sdn Bhd Malaysia
 
224-2062177-7/3/1 05-Jun-2009 80LYY 1000153953 Laglove Sdn Bhd (M) aka LA Glove Malaysia
 
930-0231761-3/1/1 08-Jun-2009 80LYY 1000283080 W.A. Rubbermate Co., Ltd. Thailand
 
930-0231761-3/1/2 08-Jun-2009 80LYY 1000283080 W.A. Rubbermate Co., Ltd. Thailand
 
930-0231761-3/1/3 08-Jun-2009 80LYY 1000283080 W.A. Rubbermate Co., Ltd. Thailand
 
930-0231761-3/1/4 08-Jun-2009 80LYY 1000283080 W.A. Rubbermate Co., Ltd. Thailand
 
M76-9910281-1/2/1 15-Jun-2009 80LYY 3005632797 Kossan Latex Industries (M) Sdn Bhd Malaysia
 
M76-9910281-1/1/1 15-Jun-2009 80LYY 1000296579 Kossan Latex Industries (M) Sdn Bhd Malaysia
 
AEK-9798866-7/2/1 22-Jun-2009 80LYY 3001441831 Ansell Medical SDN. BHD. Malaysia
 
315-7323646-5/1/1 01-Jun-2009 80LYZ 3002751308 Long First (Xiamen) Plastics Co., Ltd. China
 
E41-0061230-5/1/1 04-Jun-2009 80LYZ 3007143709 SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD China
 
E41-0061295-8/1/1 04-Jun-2009 80LYZ 3007143709 SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD China
 
DE6-3252766-4/2/1 08-Jun-2009 80LYZ 3005478299 TG Medical (China) Incorporation China
 
DE6-3252766-4/3/1 08-Jun-2009 80LYZ 3005478299 TG Medical (China) Incorporation China
 
DE6-3252766-4/1/1 08-Jun-2009 80LYZ 3005478299 TG Medical (China) Incorporation China
 
DE6-3252766-4/4/1 08-Jun-2009 80LYZ 3005478299 TG Medical (China) Incorporation China
 
E41-0061275-0/1/1/B 11-Jun-2009 80LYZ 3007143709 SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD China
 
E41-0061610-8/1/1 18-Jun-2009 80LYZ 3004532785 Shijiazhuang Brilliant Ocean Plastic Co., Ltd. China
 
UPS-1852547-1/21/1/A 19-Jun-2009 80LYZ 3003849771 Shijiazhuang Brillance Plastic Co., Ltd. China
 
UPS-1852547-1/23/1/A 19-Jun-2009 80LYZ 3003849771 Shijiazhuang Brillance Plastic Co., Ltd. China
 
UPS-1852548-9/1/1/A 19-Jun-2009 80LYZ 3003849771 Shijiazhuang Brillance Plastic Co., Ltd. China
 
UPS-1852548-9/9/1/A 19-Jun-2009 80LYZ 3003849771 Shijiazhuang Brillance Plastic Co., Ltd. China
 
UPS-1852548-9/11/1/B 19-Jun-2009 80LYZ 3003849771 Shijiazhuang Brillance Plastic Co., Ltd. China
 
UPS-1852548-9/38/1/B 19-Jun-2009 80LYZ 3003849771 Shijiazhuang Brillance Plastic Co., Ltd. China
 
UPS-1852547-1/3/1 19-Jun-2009 80LZA 3005632797 Kossan Latex Industries (M) Sdn Bhd Malaysia
 
AEK-9744544-5/2/1 23-Jun-2009 80MSN 3007471654 Schenzhen Smoore Technology Limited China
 
315-7323439-5/1/1 01-Jun-2009 80NPC 3002751308 Long First (Xiamen) Plastics Co., Ltd. China
 
UY4-0030762-4/1/1 10-Jun-2009 80NPC 3005778754 Wei Fang Jiuzhou Gloves Co., Ltd. China
 
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