BEUDAMED
    FDA Recall Terminated

    - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics Mini-Flared ABS Tip, 20 Degree Tip Angle, 45 Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics Tapered ABS MicroTip" 30 Kelman, (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309 Series 20000" Legacy TurboSonics Flared ABS MicroTip, 30 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309 Phacofragmentation system.

    Recall: Z-1642-2013 · Initiated May 3, 2013

    Recall

    Recall Number
    Z-1642-2013
    Event Number
    65205
    Firm
    Surgical Instrument Service And Savings, Inc.
    FEI Number
    3002299608
    Product Code
    NKX
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    May 3, 2013
    Posted
    July 1, 2013
    Terminated
    July 11, 2013
    Address
    2747 Sw 6th St, Redmond, OR, 97756-7109

    Description

    - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics Mini-Flared ABS Tip, 20 Degree Tip Angle, 45 Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics Tapered ABS MicroTip" 30 Kelman, (Purple/Silver) 0.9mm Ref. 8065750263 Lot 122309 Series 20000" Legacy TurboSonics Flared ABS MicroTip, 30 Degree, Kelman, (Pink) 0.9mm Ref. 8065740839 Lot. 122309 Phacofragmentation system.

    Reason

    The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

    Action

    MEDISISS sent a Correction Immediate Action Request letter dated May 2, 2013, to all affected customes. The letter identified the product, the problem, and the action to be taken by the customer. The letter directed the customer to inspect the products prior to use for seal integrity as specified on the product labeling: "Sterile unless package has been damaged or opened. Do not use if package is damaged." This will be followed up by a visit from the customer's sales representatives who are tasked with inspecting all the lots that may be remaining in the customer's inventory. The sales representative is directed to complete a "Verification of Seal Inspection" form and return it to MEDISISS Customer Relations. Devices with unacceptable seals are to be returned to MEDISISS. The sales representative is responsible for obtaining a shipping label from customer service to enable the devices to be returned to the recalling firm via Fed Ex. Customers with questions were instructed to call 866-866-7477.

    Distribution

    Nationwide Distribution.

    Quantity

    90