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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 Device Recall Oxoid Antimicrobial Susceptibility Discs FOX30, Cefoxitin see related information
Date Initiated by Firm August 21, 2012
Date Posting Updated February 12, 2013
Recall Status1 Terminated 3 on June 04, 2013
Recall Number Z-0808-2013
Recall Event ID 63556
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 KS 66215-3519
For Additional Information Contact
913-888-0939
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
Nonconforming Material/Component
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JTN and Original Applicant = OXOID U.S.A., INC.
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