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U.S. Department of Health and Human Services

Class 2 Device Recall Oxoid Antimicrobial Susceptibility Discs FOX30, Cefoxitin

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 Class 2 Recall
Oxoid Antimicrobial Susceptibility Discs FOX30, Cefoxitin
see related information
Date Posted February 12, 2013
Recall Status1 Terminated on June 04, 2013
Recall Number Z-0808-2013
Recall Event ID 63556
Premarket Notification
510(K) Number
K860153 
Product Classification Susceptibility Test Discs, Antimicrobial - Product Code JTN
Product Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.
Code Information Lot 1186069
Recalling Firm/
Manufacturer
Remel Inc
12076 Santa Fe Trail Dr
Lenexa, Kansas 66215-3519
Manufacturer Reason
for Recall
The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action The recalling firm sent a recall notification letter dated 8/17/ 2012 and 8/21/2012.
Quantity in Commerce 23 units
Distribution US Nationwide Distribution including the states of: CA, CT, GA, IA, KS, OK, RI, TX, WA, WI,
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JTN and Original Applicant = OXOID U.S.A., INC.
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