• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Oxoid Antimicrobial Susceptibility Discs FOX30, Cefoxitin

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  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/
Remel Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information Contact
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.