BEUDAMED
    FDA Recall Terminated

    FRAZIER Surgical Suction Instrument, 10 French with Control Vent and Obturator, Product Code: 0033100, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501

    Recall: Z-0560-2008 · Initiated September 12, 2007

    Recall

    Recall Number
    Z-0560-2008
    Event Number
    45862
    Firm
    Conmed Corporation
    FEI Number
    3001451571
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 12, 2007
    Posted
    February 2, 2008
    Terminated
    August 30, 2012
    Address
    525 French Road, Utica, NY, 13502-5945

    Description

    FRAZIER Surgical Suction Instrument, 10 French with Control Vent and Obturator, Product Code: 0033100, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501

    Reason

    Sterility (package integrity) compromised -- Frazier and Poole suction instruments may have an inadequate seal. The product pouch seal made during assembly of this product, may be incomplete or not present.

    Action

    URGENT-Device Recall Letters (dated 9/10/07) and FIELD CORRECTIVE ACTION CERTIFICATION forms were sent via Certified Mail to affected customers the week of 9/09/07 (mailed on 9/12/07). The recall letters informed the consignees of the recall due to potentially inadequate seals of the instruments, and instructed them to review their inventory of the instruments checking them for inadequate seals. The letters also instructed the consignees to complete the form and fax it back by 9/21/07. For those consignees that have any of the recalled instruments or may have questions, please contact ConMed Quality Assurance at 1-800-552-0138 ext. 5225 between the hours of 7 am - 6 pm (MST). International customers were notified on 9/18/07. A second recall letter (dated 10/09/07) was sent to non-respondents of the initial mailing. ConMed plans to send a third recall letter to the non-responders during the week of 12/10/07 which addresses sub-recall notifications to the distributors' customers.

    Distribution

    Nationwide and Worldwide Distribution

    Quantity

    518,622 instruments