BEUDAMED
    FDA Recall Open, Classified

    REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032

    Recall: Z-0164-2022 · Initiated September 2, 2021

    Recall

    Recall Number
    Z-0164-2022
    Event Number
    88683
    Firm
    W L Gore & Associates, Inc.
    FEI Number
    2017233
    Product Code
    MLV
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    September 2, 2021
    Address
    3750 W Kiltie Ln, Flagstaff, AZ, 86005-8712

    Description

    REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032

    Reason

    Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.

    Action

    Gore initiated distribution of "Urgent Medical Device Recall" Notification to affected consignees between the dates of September 2, 2021 - September 21, 2021. The customer communication was distributed via Email and UPS. In addition, to informing consignees about the recall, Gore asked consignees to take the following actions: 1. Identify and return any unused devices within the scope of this voluntary recall. Return Authorization number can be found on the CUSTOMER RESPONSE FORM. 2. Please complete and sign the enclosed CUSTOMER RESPONSE FORM and return to [email protected] within 3 weeks of receipt of this notification. 3. Please share this letter with others in your hospital or clinic as appropriate. 4. If a listed device has been used, there is no patient-follow up needed and there are no further actions needed other than informing Gore the device was used. Please indicate the used devices on the CUSTOMER RESPONSE FORM and return to [email protected] within 3 weeks of receipt of this letter. No further action is needed. 5. Please contact your local Gore field sales associate with any questions regarding this notice, and to coordinate the return and replacement of any unused affected devices. Additionally, you may also contact Gore Customer Service (Email: [email protected]; or by phone (U.S. toll free: (800) 528-8763)). 6. In the event that an adverse event occurs: Any adverse event involving the GORE CARDIOFORM Septal Occluder should be reported to the manufacturer and the country specific regulatory authorities immediately. To report an event to W. L. Gore & Associates, email: [email protected] or contact: USA: 800 528 1866 Ext. 44922 / 928 864 4922, Fax 928 864 4364 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

    Distribution

    US: AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE

    Quantity

    2,238 units