BEUDAMED
    FDA Recall Terminated

    Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples

    Recall: Z-1988-2013 · Initiated July 18, 2013

    Recall

    Recall Number
    Z-1988-2013
    Event Number
    65745
    Firm
    Aspen Surgical Products, Inc.
    FEI Number
    3002750084
    Product Code
    FPX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 18, 2013
    Posted
    August 20, 2013
    Terminated
    April 17, 2014
    Address
    6945 Southbelt Dr Se, Caledonia, MI, 49316-7664

    Description

    Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples

    Reason

    Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection which may require further treatment including the use of antibiotics. There have been no reports of injuries or illnesses as of 7/18/2013.

    Action

    Aspen sent an Urgent Medical Device Recall letter dated July 18, 2013 via certified mail to all customers with directions to forward the notification and provide Aspen with sub-account information. Aspen has given the customers the option to either 1.) Return the product 2.) Destroy the product with a Certificate of Destruction to be provided to Aspen. Any returned product to Aspen will be put on MRB and dispositioned by Quality. Questions or concens should be addresses to Kelli Jona Directo of QA / RA at 888-364-7004 ext 177 [email protected] or Michelle Pulaski, Quality System and Compliance Manager 888-364-7004 ext 146 [email protected] 8-5 EST M-F.

    Distribution

    Worldwide Distribution - US Nationwide in the state of Florida and in the countries of , Netherlands, and Reditch Worcestershire England

    Quantity

    3286 boxes ( 6,353,000)