BEUDAMED
    FDA Recall Terminated

    Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

    Recall: Z-0403-2022 · Initiated December 1, 2021

    Recall

    Recall Number
    Z-0403-2022
    Event Number
    89119
    Firm
    Maquet Cardiovascular, LLC
    FEI Number
    2242352
    Product Code
    MAL
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    December 1, 2021
    Terminated
    February 28, 2024
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

    Reason

    There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.

    Action

    And URGENT MEDICAL DEVICE REMOVAL notification letter dated 12/1/21 was sent to customers. Actions to be taken: " If you have already implanted one of the above-mentioned devices, kindly notify us as soon as possible by contacting your Getinge representative or Customer Service (at 1-888-943-8872, options 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. You will be contacted shortly by our Medical Affairs Officer in order to discuss the appropriate follow up. " Please examine your inventory immediately to determine if you one of the Hemashield Gold Knitted Bifurcated Vascular Graft with a Serial Number matching those listed on page 1 of this letter. " Should you have un-used affected product, you are eligible for credit or a replacement at no cost to your facility upon receipt of Response Form (see page 4). " To get your free replacement Graft we need you to provide a ship to contact and your acknowledgment on page 4. " Please contact Getinge Customer Service at 1-888-943-8872, (press option 2) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request shipping instructions to return any affected product. " Pack the product to be returned with the appropriate return documents. " Whether you have affected product or not, please complete and sign the attached URGENT MEDICAL DEVICE REMOVAL RESPONSE FORM (page 4) to acknowledge this recall and return the completed form to Getinge by e-mailing a scanned copy to [email protected] or by FAX to 877-258-1332. " Please forward this information to all current and potential Hemashield Gold Knitted Microvel double velour vascular graft users within your hopsital / facility. " If you are a distrubutor who has shipped any affected product to customers, please forward this document to their attention for appropriate action. This voluntary recall only affects the product with the serial number and lot number listed on page 1; no other products

    Distribution

    US Nationwide distribution in the states of IL and NC.

    Quantity

    2