BEUDAMED
    FDA Recall Terminated

    Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pressures. The device is offered in two configurations, one without a sideport and one with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock.

    Recall: Z-2294-2010 · Initiated July 2, 2010

    Recall

    Recall Number
    Z-2294-2010
    Event Number
    56281
    Firm
    Greatbatch Medical
    FEI Number
    2183787
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    July 2, 2010
    Posted
    August 27, 2010
    Terminated
    December 17, 2011
    Address
    2300 Berkshire Lane, North Minneapolis, MN, 55441

    Description

    Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. The OptiSeal Valved PTFE Peelable Introducer is designed to reduce blood loss and air intake by providing hemostatic sealing at venous pressures. The device is offered in two configurations, one without a sideport and one with a sideport attached to a segment of extension tubing terminating in a 3-way stopcock.

    Reason

    The outer sterile barrier (pouch) packaging for the 12 Fr device is not intact. No breaches in the inner sterile barrier (tray/tyvek lid) have been identified. The OptiSeal introducer and accessories sealed in the tray are sterile. Infection may result if a sterile field is contaminated by the outer surface of the inner tray.

    Action

    Greatbatch Medical issued an "Urgent Medical Device Recall letter dated July 12, 2010 via email to consignees. The letter described the problem and affected device. Consignees were instructed to immediately discontinue distribution of the product and return the unused units to Greatbatch Medical and to notify their customers to immediately return unused units. For shipping assistance, questions or assistance in notifying accounts, contact Shannon Springer at 763 951-8244 or Kimberly Briggs, 716 759-5702.

    Distribution

    Worldwide Distribution: United States, including the states of MN and CA.

    Quantity

    211 5-pack boxes