BEUDAMED
    FDA Recall Terminated

    COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S

    Recall: Z-0775-2019 · Initiated December 18, 2018

    Recall

    Recall Number
    Z-0775-2019
    Event Number
    81875
    Firm
    Wilson-Cook Medical Inc.
    FEI Number
    1037905
    Product Code
    FFF
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    December 18, 2018
    Terminated
    December 14, 2020
    Address
    4900 Bethania Station Rd, Winston Salem, NC, 27105-1203

    Description

    COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S

    Reason

    The product is being recalled because Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S) were mislabeled as Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) and Captura Serrated Large Forcep-No Spike (DBF-2.4SL-230-20-S) were mislabeled as Captura Serrated Forceps with Spike (DBF-2.4SN-230SP-20-S).

    Action

    The firm initiated the recall by letter in Europe on 18-December-2018 and 20-December-2018. The notices were sent in Japan today, 21-December-2018. The letter requested recall to the user level and return of the affected product.

    Distribution

    France, Ireland, Japan

    Quantity

    6 units