FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0613-03
- 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.
- Status
- Terminated
- Initiated
- 2002-12-05
- Posted
- 2003-03-06
- Terminated
- 2003-03-31
- 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.
- Lot, serial or model codes
- Lot Number: 254243 - Exp. 09/04
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTN
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28