BEUDAMED
    FDA Recall Terminated

    PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube

    Recall: Z-0411-2013 · Initiated October 17, 2012

    Recall

    Recall Number
    Z-0411-2013
    Event Number
    63629
    Firm
    Gyrus Acmi, Incorporated
    FEI Number
    3003790304
    Product Code
    ETD
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    October 17, 2012
    Posted
    November 20, 2012
    Terminated
    April 9, 2013
    Address
    136 Turnpike Road, Southborough, MA, 01772-2118

    Description

    PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube

    Reason

    One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.

    Action

    The firm, Olympus, sent an "URGENT: Medical Device Recall" letter dated October 15, 2012 to their consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to inspect their stock to confirm if any of the affected lot of product remains in their possession; immediately cease any further use of any affected product; remove it from their stockroom and quarantine it until it is shipped back to Gyrus ACMI, Inc.; call their Gyrus ACMI customer service representative (800-773-4301) to obtain a Returned Goods Authorization and promptly return any affected product to Gyrus ACMI, Inc., 2925 Appling Rd, Bartlett, TN 38133., and complete and return the RECALL REPLY FORM to Attn: Regulatory Affairs via fax to: (508) 804-2624, even if there is no affected stock left at your facility. If you have any questions, contact the customer service at 800-773-4301.

    Distribution

    Worldwide distribution: USA state of Kansas and country of Korea.

    Quantity

    10 boxes/60 units