Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartr
FDA device recall Z-0792-2014 · posted 2014-01-21 · Terminated
Recall details
- Recalling firm
- Remel Inc
- Reason for recall
- Cartridges may contain individual discs which were not impregnated with antibiotic.
- Action taken
- ThermoFisher Scientific sent a Medical Device Recall letter dated March 22, 2013, to affected customers. Letters dated April 9, 2013, were issued for the remaining three products. Customers were instructed to notify all personnel who need to be notified and review their inventory and discard any affected product. Customers were also instructed to return the attaced Medical Device Recall Response acknowleding the dispoasl of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 or 913-888-0939 (International). For questions regarding this recall call 913-895-4185.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JTN
- Quantity affected
- 9 packs
- Distribution
- Nationwide Distribution: US including Puerto Rico.
- Date initiated
- 2013-04-09
- Date posted
- 2014-01-21
- Date terminated
- 2014-01-21
- Location
- Lenexa, KS
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K973487) | Oxoid , Ltd. | 1997-10-06 |