BEUDAMED
    FDA Recall Terminated

    CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA. REF 60010.000, QTY 14 - This package contains 14 individual packs, each containing 1 sterile, single use ocular irrigation device. For external use only! Used as an ocular irrigation device.

    Recall: Z-2220-2010 · Initiated May 12, 2010

    Recall

    Recall Number
    Z-2220-2010
    Event Number
    56246
    Firm
    Insight Instruments, Inc.
    FEI Number
    1052234
    Product Code
    KYG
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    May 12, 2010
    Posted
    August 13, 2010
    Terminated
    February 16, 2012
    Address
    2580 Se Willoughby Blvd, Stuart, FL, 34994-4701

    Description

    CORNEA COAT Hydroxypropylmethylcellulose 1.5ml Syringe. STERILE, Rx ONLY. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd. Stuart, FL 34994 USA. REF 60010.000, QTY 14 - This package contains 14 individual packs, each containing 1 sterile, single use ocular irrigation device. For external use only! Used as an ocular irrigation device.

    Reason

    Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in 1.5 ml Syringe due to a potential weakness of the peel pouch seals. Products affected are Item Numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of BIOM Pack.

    Action

    All consignees were notified of the recall by letter sent via first class mail. Letter contained a Return Response Form.

    Distribution

    Worldwide Distribution -- USA, including Puerto Rico, and Frankfurt, Germany.

    Quantity

    16,128