BEUDAMED
    FDA Recall Terminated

    VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog No. 270-100, VNVD Veronikis Neo Vaginal Dilator - 1.5cm Tip:Width:0.625in Catalog No. 270-115 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 2.5cm Tip:Width:0.625in Catalog No. 270-125 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 3.5cm Tip:Width:0.625in Catalog No. 270-135 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 4.5cm Tip:Width:0.625in Catalog No. 270-145 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 5.5cm Tip:Width:0.625in Catalog No. 270-155 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Partial Taper Couple: Width:0.625in - 1in Catalog No. 270-165 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Full Taper Couple: Width:0.625in - 1in Catalog No. 270-175 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Coupler 3cm Length: Width: 1in Catalog No. 270-185 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Small Base, Screw Length 2cm Tip: Width: 1in Catalog No. 270-195 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 1.5cn Tip: Width:0.625in Catalog No. 270-199 (sold individually). For use in securing open the opening during examination of the vaginal body cavity. For the Non-Surgical Neo Vagina.

    Recall: Z-1208-2010 · Initiated April 9, 2009

    Recall

    Recall Number
    Z-1208-2010
    Event Number
    53501
    Firm
    Marina Medical Instruments Inc.
    FEI Number
    1000124817
    Product Code
    HDQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 9, 2009
    Posted
    March 25, 2010
    Terminated
    September 3, 2010
    Address
    955 Shotgun Rd, Sunrise, FL, 33326-1964

    Description

    VNVD Veronikis Neo Vaginal Dilator - Complete Set Catalog No. 270-100, VNVD Veronikis Neo Vaginal Dilator - 1.5cm Tip:Width:0.625in Catalog No. 270-115 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 2.5cm Tip:Width:0.625in Catalog No. 270-125 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 3.5cm Tip:Width:0.625in Catalog No. 270-135 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 4.5cm Tip:Width:0.625in Catalog No. 270-145 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 5.5cm Tip:Width:0.625in Catalog No. 270-155 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Partial Taper Couple: Width:0.625in - 1in Catalog No. 270-165 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Full Taper Couple: Width:0.625in - 1in Catalog No. 270-175 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Coupler 3cm Length: Width: 1in Catalog No. 270-185 (sold individually), VNVD Veronikis Neo Vaginal Dilator - Small Base, Screw Length 2cm Tip: Width: 1in Catalog No. 270-195 (sold individually), VNVD Veronikis Neo Vaginal Dilator - 1.5cn Tip: Width:0.625in Catalog No. 270-199 (sold individually). For use in securing open the opening during examination of the vaginal body cavity. For the Non-Surgical Neo Vagina.

    Reason

    Marina Medical, Sunrise, FL initiated recall of 46 products of 350 series devices and 47 products of 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary skin or tissue irritation.

    Action

    A "PRODUCT RECALL NOTICE" letter dated April 8, 2009, was sent to the customers. The letter describes the product, problem and the action to be taken by the customers. The customers are asked to identify the subject part in their instrument inventory and quarantine it. The Quality Control team at Marina Medical will contact the customer with instructions to return the part. When contacted, the customer should report any incidents of adverse reactions that have been observed at their institution. If you have any questions, please call 1-800-697-1119 ore (954) 924-4418.

    Distribution

    Nationwide distribution.

    Quantity

    22