BEUDAMED
    FDA Recall Open, Classified

    Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

    Recall: Z-1626-2020 · Initiated February 27, 2020

    Recall

    Recall Number
    Z-1626-2020
    Event Number
    85034
    Firm
    Gentell, Inc
    FEI Number
    1000522686
    Product Code
    FRO
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    February 27, 2020
    Posted
    March 5, 2020
    Address
    2701 Bartram Rd, Bristol, PA, 19007-6810

    Description

    Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

    Reason

    During an FDA audit, it was discovered that the product was not properly registered with FDA.

    Action

    On February 27, 2020, the firm notified customers by distributing Urgent Medical Device Recall letters. Customers were informed that the products were not properly registered with the FDA, and that the firm is discontinuing the product permanently. Customers were asked to quarantine and return the product. To return product, customers are to complete the response form included with the letter and fax or email it back to the firm. A quality representative will contact customers with a return goods authorization number, provide instruction for the return of the product(s) to Gentell, and arrange for any refund that may be due. The response form should be completed and returned even if customers have no affected stock on hand. Customers with questions should contact Valerie Falkenberg, Monday through Friday, 9:00 AM to 5:00 PM, Eastern Time, 800-840-9041 or [email protected].

    Distribution

    Worldwide distribution US Nationwide distribution in the states of AL, CA, FL, IA, IL, KY, MA, MI, MN, NC, NJ, NY, OH, OK, PA, Puerto Rico, RI, SC, TN, TX, WI and countries of Panama, South Africa, Bahrain, Spain, Mexico, Costa Rica, Romania.

    Quantity

    6,395