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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
UPS-1000586-4/1/3 23-May-2008 80BRZ 3004586161 Jose Armando Yanez Barron Mexico
 
224-0360913-8/1/24 23-May-2008 80FMI 1282497 Covidien LLC United States
 
231-5460670-3/1/1 20-May-2008 80FMJ 3002807391 Nellcor Puritan Bennett Mexico, S.A. de C.V. Mexico
 
231-5460670-3/2/1 20-May-2008 80FMJ 3002807391 Nellcor Puritan Bennett Mexico, S.A. de C.V. Mexico
 
224-0360913-8/1/12 23-May-2008 80FOZ 1000165314 Central Admixture Pharmacy Inc. United States
 
FR1-0012240-2/1/1 23-May-2008 80FRN 3007363456 Tianjin Hanaco Xingda Medical Co., Ltd. China
 
224-0360913-8/1/19 23-May-2008 80JOK 1419843 Armstrong Medical Industries Inc. United States
 
ARE-4095895-6/1/1 01-May-2008 80KGX 3003844446 Shanghai Huazhou PSA Products Co., Ltd. China
 
ARE-4095720-6/1/1 02-May-2008 80KGX 3003844446 Shanghai Huazhou PSA Products Co., Ltd. China
 
EQ6-0007691-1/1/1 21-May-2008 80LDQ 3000183921 Elmed Instruments Pvt. Ltd. Pakistan
 
EQ6-0007697-8/1/1 21-May-2008 80LDQ 1000300246 Jota AG Switzerland
 
224-0360913-8/1/13 23-May-2008 80LHI 1713468 ICU Medical (Utah) Inc. United States
 
UPS-1126704-2/1/1/D 27-May-2008 80LHI 3002518185 Bu Kwang Trading Inc Korea, Republic Of (South)
 
UPS-1126704-2/1/1/E 27-May-2008 80LHI 5597 Hindustan Syringes Pvt. Ltd. India
 
224-0360913-8/1/18 23-May-2008 80LZC 1000138386 Medline Industries, Inc United States
 
AEK-7972618-4/1/1 20-May-2008 80MXI 3006736148 Xinhua Egm Co. China
 
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