BEUDAMED
    FDA Recall Open, Classified

    FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510

    Recall: Z-1747-2022 · Initiated August 2, 2022

    Recall

    Recall Number
    Z-1747-2022
    Event Number
    90808
    Firm
    Carwild Corporation
    FEI Number
    1219313
    Product Code
    EFN
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    August 2, 2022
    Address
    3 State Pier Rd, New London, CT, 06320-5817

    Description

    FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510

    Reason

    Sterility with new cotton source not validated

    Action

    Carwild Corp. issued Recall Urgent Notice via email on 8/2/22 in a pdf form fillable document for Distributors/Direct accounts to complete and return. Letter states reason for recall, health risk and action to take: 1. Discontinue use of this product and Immediately place inventory of this product on HOLD. Distributors to provide traceability of lot. 2. Complete and return the attached RECALL NOTICE to us. 3. Once we receive the completed RECALL NOTICE, we will make arrangements for the product to be returned. Please respond immediately to confirm receipt of this email. Call for questions or additional Regulatory (Voice) information. 1-860-442-4914 x111 Please introduce as inquiry Customer Service related to RECALL NOTICE 1-860-442-4914 x110. PRODUCT RECALL and RESPONSE : [email protected] customerservice(@carwild.net

    Distribution

    US Nationwide

    Quantity

    90 CASES (4500 EACHES)