BEUDAMED
    FDA Recall Terminated

    Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 Disposable laryngoscope blades

    Recall: Z-3213-2011 · Initiated March 10, 2011

    Recall

    Recall Number
    Z-3213-2011
    Event Number
    58820
    Firm
    Penlon, Ltd. (Fmly East Healthcare) Abingdon Science Park Barton Lane Abingdon United Kingdom
    FEI Number
    3002807907
    Product Code
    CCW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 10, 2011
    Posted
    September 14, 2011
    Terminated
    September 21, 2012

    Description

    Crystal Metal Miller Disposable Blades (sizes 0 art no: 50676 and 00 part no 50647 Disposable laryngoscope blades

    Reason

    Disposable laryngoscope blades incorrectly labeled with wrong size.

    Action

    Penlon Ltd ( frmly East Healthcare ) sent an " Urgent Field Safety Notice" dated March 7, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to check their stock with expiry dates between August 2010 to July 2015, and ensure that the sizes written on the blades, inner plastic bags, and the carton all match. Please complete the reply form below and send to the address provided. If you have any stock where the sizes on the bags, blades, and carton do not match, quarantine the blades and contact Penlon using the information below. For further questions please call 44 1235 547093.

    Distribution

    Worldwide Distribution -- USA (nationwide) including the states of CA, VA and WI., and the countries of Belgium, Ireland, France, Netherlands, Norway, Portugal, Switzerland, UK, Hong Kong, Greece, Bahrain and China.

    Quantity

    5 cartons (20 blades each)