BEUDAMED
    FDA Recall Terminated

    Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.

    Recall: Z-2755-2016 · Initiated June 27, 2016

    Recall

    Recall Number
    Z-2755-2016
    Event Number
    74584
    Firm
    Aspen Surgical Puerto Rico Corp. Rd 183 Km 20.3 Las
    FEI Number
    2649798
    Product Code
    GES
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    June 27, 2016
    Posted
    September 8, 2016
    Terminated
    May 15, 2017
    Address
    Piedras, PR, 00771

    Description

    Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.

    Reason

    After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil pack as 12 instead of 12B.

    Action

    An "Urgent: Medical Device Correction" letter was sent on June 27, 2016. The letter provided background on the issue, as well as actions to be taken by the user. Customers have the alternative to either keep the product or return it for replacement. A response form was included for customers to complete and return. Customers are to maintain awareness of the incorrect identification prior to use. Questions concerning the correction can be directed to [email protected].

    Distribution

    US distribution only.

    Quantity

    6,000 pieces