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U.S. Department of Health and Human Services

Class 3 Device Recall CXM 30

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  Class 3 Device Recall CXM 30 see related information
Date Initiated by Firm December 05, 2002
Date Posted March 06, 2003
Recall Status1 Terminated 3 on March 31, 2003
Recall Number Z-0613-03
Recall Event ID 25250
Product Classification Susceptibility Test Discs, Antimicrobial - Product Code JTN
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.
Code Information Lot Number: 254243 - Exp. 09/04
Recalling Firm/
Manufacturer		 Remel, Inc.
12076 Santa Fe Dr
Lenexa KS 66215
Manufacturer Reason
for Recall		 Packages of Cefuroxime susceptibility disks erroneously contained Cefaclor susceptibility disks.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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