BEUDAMED
    FDA Recall Terminated

    The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting step, including cumbersome autoclave techniques. The collagen is designed to be gradually resorbed by the patient. The CONCENTRICRIMP pleat and GUIDELINE stripe are also featured. In addition to collagen, the graft also contains glycerol as a softening agent.

    Recall: Z-2559-2019 · Initiated August 22, 2019

    Recall

    Recall Number
    Z-2559-2019
    Event Number
    83664
    Firm
    GETINGE US SALES LLC
    FEI Number
    3012092534
    Product Code
    MAL
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 22, 2019
    Terminated
    April 27, 2020
    Address
    45 BARBOUR POND DR, WAYNE, NJ, 07470

    Description

    The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting step, including cumbersome autoclave techniques. The collagen is designed to be gradually resorbed by the patient. The CONCENTRICRIMP pleat and GUIDELINE stripe are also featured. In addition to collagen, the graft also contains glycerol as a softening agent.

    Reason

    Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size of 16 x 9 mm is likely incorrectly packed inside of the carton which was labeled to contain a HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product with the diameter size of 16 x 8 mm ((REF: M00202166168P0, Lot: 18K31, SN: 1190443415, size 16 x 8 mm).

    Action

    1. Please examine your inventory immediately to determine if you have the HEMASHIELD PLATINUM Woven Double Velour Vascular Graft product. 2. Please remove the affected product from areas of use. 3. Affected product should be returned to Getinge per the following process: Please complete the Urgent Medical Device Recall Removal Response Form to acknowledge that you have received this Urgent Medical Device Recall Removal letter. Please fax or email the completed form to Getinge office as instructed on the form. Please contact Getinge Customer Service at 18886278383 (press option 2, then option 5) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request a shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at +1 8886278383 (press option 2, then option 5), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone)

    Distribution

    US state of NJ

    Quantity

    1 unit