BEUDAMED
    FDA Enforcement Class II 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 · Reported July 12, 2017

    Enforcement

    Recall Number
    Z-2687-2017
    Event ID
    77482
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mallinckrodt Manufacturing LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 12, 2017
    Initiation Date
    October 17, 2014
    Classification Date
    July 6, 2017
    Termination Date
    July 15, 2017
    Address
    835 Maude Ave, N/A, Mountain View, CA, 94043-4021, United States

    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.

    Code Info

    Lot Numbers: (a) 211300001, 20928001, 30308001, 30329001, 3092001, 31113001, 40108002, 40129001, 40226001, 40430001 (b) 40611001

    Distribution

    Worldwide Distribution to the country : UK

    Quantity

    246 units