BEUDAMED
    FDA Recall Terminated

    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

    Recall: Z-1637-2015 · Initiated May 2, 2015

    Recall

    Recall Number
    Z-1637-2015
    Event Number
    71191
    Firm
    Synovis Surgical Innovations, Inc.
    FEI Number
    2183620
    Product Code
    DXZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 2, 2015
    Posted
    May 29, 2015
    Terminated
    February 18, 2016
    Address
    2575 University Ave W, Saint Paul, MN, 55114-1073

    Description

    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

    Reason

    Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface.

    Action

    The firm, Baxter, sent an "Urgent Product Recall" letter dated 5/2/2015 via USPS overnight delivery to its customers. The letter identified the affected product, problem and actions to be taken. The customers were instructed to immediately discontinue use and segregate the affected product, locate and remove all affected product from your facility and to return it to Baxter. Customers are to contact Baxter Healthcare Center, 888-229-0001, for Service to arrange for return and credit. In addition, the customers were to complete and return the Customer Reply Form by faxing to 224-270-5457 or emailing to [email protected]. If you have any questions, contact Director, Quality at 651-796-7543 or email: [email protected].

    Distribution

    Nationwide Distribution.

    Quantity

    3,974