BEUDAMED
    FDA Recall Terminated

    Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736

    Recall: Z-1041-2019 · Initiated February 15, 2019

    Recall

    Recall Number
    Z-1041-2019
    Event Number
    82245
    Firm
    COVIDIEN LLC
    FEI Number
    1282497
    Product Code
    JOW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 15, 2019
    Terminated
    July 24, 2020
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736

    Reason

    The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.

    Action

    Urgent Medical Device Recall notification letters dated 2/15/19 were sent to customers. An additional customer was identified and a letter was sent on 3/11/19.

    Distribution

    The products were distributed to the following US states: CA, NJ, and WA.

    Quantity

    25 units