| Class 2 Device Recall Oxoid Antimicrobial Susceptibility Discs FOX30, Cefoxitin | |
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 |
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. |
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 |
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 |
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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
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