BEUDAMED
    FDA Recall Terminated

    Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients

    Recall: Z-1226-2016 · Initiated January 22, 2016

    Recall

    Recall Number
    Z-1226-2016
    Event Number
    73121
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    EZL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 22, 2016
    Posted
    March 21, 2016
    Terminated
    June 20, 2017
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for male and female patients

    Reason

    Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

    Action

    Medtronic/Covidien notfiied customersl via Federal Express on January 22, 2016,, The letter instructs customers to not use the Castile Soap Towelettes contained in the product kits listed on Attachment 1 and discard the affected towelettes. The Castile Soap packet included in these kits does not impact the integrity of the remaining products in the kit. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878. For questions regarding this recall call 203-492-5000.

    Distribution

    US (nationwide) and to Canada.

    Quantity

    1950