BEUDAMED
    FDA Recall Terminated

    AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08

    Recall: Z-0785-2018 · Initiated June 22, 2017

    Recall

    Recall Number
    Z-0785-2018
    Event Number
    79162
    Firm
    Avid Medical, Inc.
    FEI Number
    1047429
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 22, 2017
    Terminated
    October 12, 2018
    Address
    9000 Westmont Dr, Toano, VA, 23168-9351

    Description

    AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08

    Reason

    Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.

    Action

    An email notification was sent to all sales representatives with the BD recall notification and the following instructions: " Examine inventory for the affected AVID catalog numbers and lots noted in the Where Used Chart. If affected product is found: (1) discontinue use and quarantine impacted product immediately; and (2) promptly apply a recall label to each affected lot found. Once labeled with the recall label, product may be taken out of quarantine and made available for use. " All other components in the MAI/ AVID tray are unaffected by this recall and may safely be used. Labels may be printed using the label template attached. Or, upon receiving the following information I will be happy to overnight the required labels. Any revisions or alterations to the labels are prohibited. " Label Quantity- 1 for each affected tray, plus 1 for each outside carton. " Contact Name " Address " Phone Number Sales representatives were asked to confirm to [email protected] that your customers were notified.

    Distribution

    Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.

    Quantity

    597