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U.S. Department of Health and Human Services

Class 2 Device Recall CaviBleach Wipes

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 Class 2 Recall
CaviBleach Wipes
see related information
Date Posted June 22, 2010
Recall Status1 Terminated on June 23, 2010
Recall Number Z-1815-2010
Recall Event ID 55051
Product Classification Disinfectant, Medical Devices - Product Code LRJ
Product CaviBleach Wipes; a disinfectant medical device, active ingredient Sodium hypochlorite 0.525%; a single 9" x 9" towelette, pre-moistened with 0.525% - 0.656% sodium hypochlorite, packaged in a flexible poly foil pouch, 50 wipes per dispenser box, 8 boxes per case; Manufactured for Metrex Research Corporation, 28210 Wick Road, Romulus, MI 48174. General purpose disinfectant wipe for hard, non-porous surfaces, patient care equipment and point of care equipment.
Code Information Reorder No. 10-1155, LotF29, Exp June 2010
Recalling Firm/
Manufacturer
Medtrol, Inc.
7157 N Austin Ave
Niles, Illinois 60714-4617
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. Paul W. Stiffler, Ph.D.
800-647-7180
Manufacturer Reason
for Recall
The disinfectant wipes were found out of specifications for the disinfectant activity prior to the expiration date.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Medtrol telephoned Metrex on December 2, 2009, informing them that Medtrol was requesting the recall of the affected product. Metrex sent Urgent Medical Device Recall letters dated December 3, 2009 to their accounts, requesting them to examine their inventory for the affected product, and return any found for credit. They also requested their accounts to sub-recall the product to the retail level. Metrex also requested their accounts to complete and return the enclosed reply sheet, acknowledging receipt of the recall letter and indicating the amount of product being returned. For further information, contact Metrex Customer Care Center at 1-800-841-1428.
Quantity in Commerce 150 cases
Distribution Nationwide Distribution -- Including state of Michigan.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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