BEUDAMED
    FDA Recall Terminated

    Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during vascular interventional procedures. SafeSheath Sealing Adapter, Part No. FCL-094-03, Catalog No. SSSA-EW-09; SafeSheath Sealing Adapter, Part No. FCL-141-01, Catalog No. 369826; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07; Transvalvular Insertion Tool (TVI), Part #MIS-122-00, Catalog No. TVI-09; and CPS SafeSheath Sealing Adapter, Part No. XD-2754-00, Catalog No. 410195.

    Recall: Z-1227-2011 · Initiated December 16, 2010

    Recall

    Recall Number
    Z-1227-2011
    Event Number
    57679
    Firm
    Thomas Medical Products Inc
    FEI Number
    3010665433
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 16, 2010
    Posted
    February 14, 2011
    Terminated
    August 8, 2012
    Address
    65 Great Valley Pkwy, Malvern, PA, 19355-1302

    Description

    Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during vascular interventional procedures. SafeSheath Sealing Adapter, Part No. FCL-094-03, Catalog No. SSSA-EW-09; SafeSheath Sealing Adapter, Part No. FCL-141-01, Catalog No. 369826; Transvalvular Insertion Tool (TVI), Part #MIS-099-00, Catalog No. TVI-07; Transvalvular Insertion Tool (TVI), Part #MIS-122-00, Catalog No. TVI-09; and CPS SafeSheath Sealing Adapter, Part No. XD-2754-00, Catalog No. 410195.

    Reason

    Compromised sterility/weak or open seals.

    Action

    GE Healthcare Thomas medical products Recall notification dated 16 December 2010 (GEHC Ref # 35003) was sent by letter via UPS Next Day Air and/or USPS certified mail.

    Distribution

    Distribution Nationwide USA and Germany.

    Quantity

    28,679 for all products