BEUDAMED
    FDA Recall Terminated

    Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.

    Recall: Z-1995-2012 · Initiated June 1, 2012

    Recall

    Recall Number
    Z-1995-2012
    Event Number
    61958
    Firm
    PSC Industries Inc
    FEI Number
    3000719969
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 1, 2012
    Posted
    July 12, 2012
    Terminated
    September 15, 2015
    Address
    3230 Commerce Center Pl, Louisville, KY, 40211-1900

    Description

    Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.

    Reason

    Firm officials reported to CIN-DO that their Electrosurgical Monopolar Reusable Bayonet Forceps are misbranded in that the label states that the tip size is: (0.5mm) when the tip size actually measures (1.0mm).

    Action

    The firm, Olsen Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 5, 2012 to their customers via Certified mail along with representative labeling to illustrate the specific labeling issue associated with the various types and/or sizes of Bayonet Forceps surgical instruments that the customers received. The letter described the product, problem and actions to be taken. The letter instructed the customers to immediately examine their inventory for the presence of the suspect product and quarantine the product, if found; to discontinue use immediately and promptly call (800) 251-3000 for a 'Return Material Authorization (RMA) number; to complete and return the enclosed 'Recall Response Form' and fax the completed form to the fax number on the form or to send the completed form back to the recalling firm via parcel post, and for customers who may have further distributed the recalled product are asked to contact their (sub-account) customers and notify them of the recall. If you have any questions call (615) 964-5515 M-F 8:00 am - 5:00 pm CST.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.

    Quantity

    5 units