BEUDAMED
    FDA Recall 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.

    Recall: Z-1815-2010 · Initiated December 2, 2009

    Recall

    Recall Number
    Z-1815-2010
    Event Number
    55051
    Firm
    Medtrol, Inc.
    FEI Number
    3002513493
    Product Code
    LRJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 2, 2009
    Posted
    June 22, 2010
    Terminated
    June 23, 2010
    Address
    7157 N Austin Ave, Niles, IL, 60714-4617

    Description

    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.

    Reason

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

    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.

    Distribution

    Nationwide Distribution -- Including state of Michigan.

    Quantity

    150 cases