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Terminated

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.

FDA Recall Z-1815-2010 · Posted 2010-06-22

Recalling FirmMedtrol, Inc.
Recall StatusTerminated
Product CodeLRJ
Date Initiated2009-12-02
Date Terminated2010-06-23
Product Quantity150 cases

Reason for Recall

The disinfectant wipes were found out of specifications for the disinfectant activity prior to the expiration date.

Firm 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.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution -- Including state of Michigan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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