BEUDAMED
    FDA Recall Terminated

    PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.

    Recall: Z-1347-2013 · Initiated February 15, 2013

    Recall

    Recall Number
    Z-1347-2013
    Event Number
    64618
    Firm
    Unimed Surgical Products, Inc.
    FEI Number
    1000307745
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    February 15, 2013
    Posted
    May 22, 2013
    Terminated
    August 7, 2013
    Address
    10401 Belcher Rd S, Largo, FL, 33777-1415

    Description

    PROGRESSIVE MEDICAL Laparoscopic Electrode PTFE Coated L Hook 33cm. Intended for the cutting of soft tissue and coagulation.

    Reason

    Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.

    Action

    Unimed Surgical Products, Inc. issued a Medical Device Correction and Removal letter dated February 15, 2013 to its customers. Customers were instructed to quarantine any undistributed product, and notify its customers of the recall to retrieve any unused product. For further information, contact Unimed Surgical Products Inc. at 1-800-531-2627.

    Distribution

    Distributed in the states of MO, TN, and PA.

    Quantity

    120,416 units