Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges
FDA device recall Z-0808-2013 · posted 2013-02-12 · Terminated
Recall details
- Recalling firm
- Remel Inc
- Reason for recall
- The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic.
- Action taken
- The recalling firm sent a recall notification letter dated 8/17/ 2012 and 8/21/2012.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JTN
- Quantity affected
- 23 units
- Distribution
- US Nationwide Distribution including the states of: CA, CT, GA, IA, KS, OK, RI, TX, WA, WI,
- Date initiated
- 2012-08-21
- Date posted
- 2013-02-12
- Date terminated
- 2013-06-04
- Location
- Lenexa, KS
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS (K860153) | Oxoid U.S.A., Inc. | 1986-03-04 |