BEUDAMED
    FDA Recall Terminated

    PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.

    Recall: Z-0732-2016 · Initiated December 1, 2015

    Recall

    Recall Number
    Z-0732-2016
    Event Number
    73007
    Firm
    JosNoe Medical, Inc.
    FEI Number
    3000718286
    Product Code
    NWV
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 1, 2015
    Posted
    January 30, 2016
    Terminated
    March 22, 2016
    Address
    1303 S Main St, Chelsea, MI, 48118-1483

    Description

    PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.

    Reason

    Damage to package seals potentially compromising sterility.

    Action

    On 12/1/2015, notifications were sent to the affected customers via e-mail. The recall notification included a description of the reason for the recall, the affected product, and instructions for identifying and returning the affected product.

    Distribution

    Distributed US (nationwide) and in Canada.

    Quantity

    1008 boxes