—#25822

Product

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.

FDA product code: JTN — Susceptibility Test Discs, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: Lot Number: 254243 - Exp. 09/04

Why it was recalled

Packages of Cefuroxime susceptibility disks erroneously contained Cefaclor susceptibility disks.

Root cause (FDA determination)

Other

Action the firm took

Recall letters dated 12/5/02 were issued requesting destruction of the product by the customer.

Recalling firm

Firm: Remel, Inc.
Address: 12076 Santa Fe Dr, Lenexa, Kansas 66215

Distribution

Distribution pattern: The product was distributed nationwide to 62 medical facilities including 3 military and 4 government accounts. No foreign accounts were reported.

Timeline

Recall initiated: 2002-12-05
Posted by FDA: 2003-03-06
Terminated: 2003-03-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #25822. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.