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Class 2 Device Recall Oxoid Antimicrobial Susceptibility Discs FOX30, Cefoxitin |
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Date Initiated by Firm |
August 21, 2012 |
Date Posted |
February 12, 2013 |
Recall Status1 |
Terminated 3 on June 04, 2013 |
Recall Number |
Z-0808-2013 |
Recall Event ID |
63556 |
510(K)Number |
K860153
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Product Classification |
Susceptibility test discs, antimicrobial - Product Code JTN
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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.
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Code Information |
Lot 1186069 |
Recalling Firm/ Manufacturer |
Remel Inc 12076 Santa Fe Trail Dr Lenexa KS 66215-3519
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For Additional Information Contact |
913-888-0939
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Manufacturer Reason for Recall |
The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
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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
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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.
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510(K) Database |
510(K)s with Product Code = JTN and Original Applicant = OXOID U.S.A., INC.
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