Z-0613-03

REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a cartridge, 5 cartridges...

Name: Z-0613-03 REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a cartridge, 5 cartridges...
Creator: Remel, Inc.
Published: 2002-12-05
License: https://open.fda.gov/license/

Remel Inc / initiated 2002-12-05 / Terminated / root cause: packaging

FDA source

Remel, Inc. began a recall of 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... on 2002-12-05. The reason FDA records is "Packages of Cefuroxime susceptibility disks erroneously contained Cefaclor susceptibility disks". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0613-03
Status: Terminated
Initiated: 2002-12-05
Posted: 2003-03-06
Terminated: 2003-03-31
Recalling firm: Remel Inc
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.
Product code: JTN Susceptibility Test Discs, Antimicrobial
Reason for recall: Packages of Cefuroxime susceptibility disks erroneously contained Cefaclor susceptibility disks.
Root cause tag: packaging
FDA root cause: Other
Action: Recall letters dated 12/5/02 were issued requesting destruction of the product by the customer.
Quantity in commerce: 104 Pkg
Distribution: The product was distributed nationwide to 62 medical facilities including 3 military and 4 government accounts. No foreign accounts were reported.
Product codes and lots: Lot Number: 254243 - Exp. 09/04

Product code JTN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)