BEUDAMED
    FDA Recall Terminated

    Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers 50675, 50675/F, 50675/BMI) Product Usage: Disposable laryngoscope blades.

    Recall: Z-1221-2012 · Initiated September 21, 2011

    Recall

    Recall Number
    Z-1221-2012
    Event Number
    59992
    Firm
    Penlon, Ltd. Abingdon Science Park Barton Lane Abingdon United Kingdom
    FEI Number
    3002807907
    Product Code
    CCW
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 21, 2011
    Posted
    March 18, 2012
    Terminated
    June 19, 2012

    Description

    Crystal Metal Disposable Blades size Mac 4 (part number 50674, 50674/F, 50674/BMI) and Mac 3 (part numbers 50675, 50675/F, 50675/BMI) Product Usage: Disposable laryngoscope blades.

    Reason

    Disposable laryngoscope blades incorrectly labeled with wrong size.

    Action

    InterMed Penlon sent and Urgent Field Safety Notice letter dated September 21, 2011 to affected customers. The letter identified the affected product, problem and advice on actions to be taken by user. Customers were instructed to complete the Reply Form and send to the address provided.

    Distribution

    Worldwide Distribution - USA (nationwide) in the countries of Belgium, France, Greece, Ireland, Italy, Lithuania, Netherlands, Norway, Portugal, Switzerland, Canada, China, Hong Kong and Malaysia.

    Quantity

    24,940 cartons