BEUDAMED
    FDA Recall Terminated

    Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery.

    Recall: Z-2687-2017 · Initiated October 17, 2014

    Recall

    Recall Number
    Z-2687-2017
    Event Number
    77482
    Firm
    Mallinckrodt Manufacturing LLC
    FEI Number
    3006472186
    Product Code
    NBE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 17, 2014
    Posted
    July 6, 2017
    Terminated
    July 15, 2017
    Address
    835 Maude Ave, Mountain View, CA, 94043-4021

    Description

    Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery.

    Reason

    Product was improperly labeled leading to improper storage.

    Action

    The direct consignee was notified by email on October 17, 2014. The action requested to be taken on receipt of the notice: " Remove all ArterX delivered by CJ Medical from inventory and quarantine for return to CJ Medical. " Return the product to CJ Medical for a credit or product replacement " If no ArterX is found in inventory, please comment to that effect on the attached form and return the form to CJ Medical. The consignee was also requested to circulate the Field Safety Notice among all users affected by this product. For further questions, please call (314) 654-2000.

    Distribution

    Worldwide Distribution to the country : UK

    Quantity

    246 units