BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1347-2013 · Reported May 29, 2013

    Enforcement

    Recall Number
    Z-1347-2013
    Event ID
    64618
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Unimed Surgical Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2013
    Initiation Date
    February 15, 2013
    Classification Date
    May 21, 2013
    Termination Date
    August 7, 2013
    Address
    10401 Belcher Rd S, N/A, Largo, FL, 33777-1415, United States

    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.

    Code Info

    Lot Numbers: 071212-02, 071212-03, 071212-05, 071212-01, 071212-06, 082712-02, 071212-04, 082712-04, 082712-05, 082712-13, 071212-07, 082712-07, 082712-09, 082712-03, 082712-15, 082712-14, 081712-06, 082712-01, 082712-10, 081512-06, 080612-01, 081512-07, 082712-12, 081512-04, 082712-11, 081012-01, 080612-03, 080612-02, 080612-04, 071612-05, 071612-04, 080612-05, 080612-07, 081312-11, 071612-03, 081312-10, 071912-01, 071912-02, 092812-02, 092812-03, 092812-04, 092812-05, 092812-06, 092812-07, 091312-01, 100812-02, 072312-01, 080612-08, 081312-01, 100112-01, 091312-04, 082312-04, 082312-03, 082312-06, 082312-05, 082812-02, 111212-01, 111212-03, 111212-02, 082312-02, 092812-02, 092812-07, 092812-06, 111212-19, 111212-18, 111212-18, 111212-19, 100212-01, 100312-06, 111212-11, 111212-07, 081512-05, 111212-04, 100312-01, 100312-03, 091312-02, 091312-03, 100312-08, 100312-09, 100312-10, 100312-01, 100312-03, 100312-04, 111212-14, 111212-10, 111212-08, 111212-07, 111212-17, 111212-20, 111212-21, 121012-03, 120612-01, 111212-12, 121012-01, 112112-01, 112112-02, 112112-03, 112112-04, 112112-06, 011113-04, 100312-02, 011013-10, 092812-01, 091912-02, 100312-05, 011013-12, 011013-05, 092812-02, 111212-16, 011013-04, 011013-07, 011013-08, 100312-13, 011013-02, 111212-09, 111212-11, 011013-11, 111212-13, 111212-15, 092812-03, 012213-02, 111212-12, 011013-13, 012213-01, 012213-04 011013-09, 011413-02, 012213-03, 011413-03, 011413-04, 111212-16, 011013-06, 012913-01, 012913-02, 111212-05, 012913-03, 012913-09, 012813-01.

    Distribution

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

    Quantity

    120,416 units