Recall Z-0613-03 ยท JTN Susceptibility Test Discs, Antimicrobial
Remel, Inc.
REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a cartridge, 5 cartridges to a kit, catalog Number 33999. The label shows the product is ''Mfg for'' REMEL, Lenexa,KS.
| Date | Mar 6, 2003 (initiated Dec 5, 2002) |
| Status | Terminated |
| Reason | Packages of Cefuroxime susceptibility disks erroneously contained Cefaclor susceptibility disks. |
| Root cause | Other |
| Action | Recall letters dated 12/5/02 were issued requesting destruction of the product by the customer. |
| Quantity | 104 Pkg |
| Distribution | The product was distributed nationwide to 62 medical facilities including 3 military and 4 government accounts. No foreign accounts were reported. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.