BEUDAMED
    FDA Recall Terminated

    InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA.

    Recall: Z-1800-2010 · Initiated May 10, 2010

    Recall

    Recall Number
    Z-1800-2010
    Event Number
    55674
    Firm
    Inviro Medical Devices, Inc
    FEI Number
    3005147037
    Product Code
    MEG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 10, 2010
    Posted
    June 11, 2010
    Terminated
    December 8, 2011
    Address
    1755 N Brown Rd, Ste 150, Lawrenceville, GA, 30043-8194

    Description

    InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA.

    Reason

    Syringe Defects. Group 1 syringes: The plunger pull out force was below specification. Group 2 syringes: The needle length is out of specification.

    Action

    Consignees were notified by letter on or about 05/10/2010. Consignees were instructed to review their inventory of InviroSnap Safety Syringes for the lot numbers and remove them from inventory and to return the affected product to Inviro Medical. They were instructed to pass on the information to anyone who uses or orders Inviro Snap Safety Syringes at their facility and to ensure a copy of the letter is provided to any other organizations to which affected devices have been transferred. A Response Card was included to be completed and faxed back to Inviro Medical Devices even if there is no product in inventory to verify receipt of notification. Questions regarding the recall were directed to the company's Customer Service number at (866) 914-2259. All product from Group 1 will be scrapped. Product from Group 2 will be retained in Quarantine until such time as the product can be exported the permission of the importing countries Ministry of Health.

    Distribution

    CA, FL, IL, MI, MO, MN, NC, OH, TX; and Canada

    Quantity

    623,000 units