BEUDAMED
    FDA Recall Open, Classified

    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375

    Recall: Z-2293-2021 · Initiated May 12, 2021

    Recall

    Recall Number
    Z-2293-2021
    Event Number
    88245
    Firm
    W L Gore & Associates, Inc.
    FEI Number
    2017233
    Product Code
    DSY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 12, 2021
    Address
    3750 W Kiltie Ln, Flagstaff, AZ, 86005-8712

    Description

    Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers: HPT060015 UDI: (01)00733132606368 HPT060015A UDI: (01)00733132606375

    Reason

    Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are incorrectly labeled as 6 mm.

    Action

    On May 10, 2021, Gore issued a "Medical Device Recall" notification to affected customers via USPS. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. Identify and return any unused devices within the scope of this voluntary recall. 2. Please complete and sign the enclosed CUSTOMER RETURN FORM and return to [email protected] within 2 weeks of receipt of this notification. 3. Please share this letter with others in your hospital or clinic as appropriate. Please transfer this notice to other organization(s) as appropriate. 4. Any adverse event involving the GORE PROPATEN Vascular Graft configured for Pediatric Shunt should be reported to the manufacturer and the country specific regulatory authorities immediately. A. To report an event to W. L. Gore & Associates, email: [email protected], or contact: USA: +1 800 528 1866 Ext. 44922 / +1 928 864 4922, Fax +1 928 864 4364 EMEA: +49 89 4612 3440, Fax +49 89 4612 43440 Brazil: +55 11 5502-7953, Fax: +55 11 5502-7965 B. For US Customers only: Healthcare professionals and consumers may report adverse events or quality problems directly to FDA using the FDA MedWatch Website:https://www.accessdata.fda.gov/scripts/medwatch/index.cfm 5. Please feel free to contact Gore Customer Service (email: [email protected]) or Uzma Tahir, Ph.D. (928-864-3779/[email protected]) if you have questions or concerns regarding this voluntary recall.

    Distribution

    US: NE, DC, MA, KY, IL, WA, MD, CA, AZ, GA OUS: Canada, Brazil, Europe, Saudi Arabia