BEUDAMED
    FDA Recall Terminated

    LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.

    Recall: Z-1446-2013 · Initiated April 4, 2013

    Recall

    Recall Number
    Z-1446-2013
    Event Number
    64968
    Firm
    Leica Microsystems, Inc.
    FEI Number
    3000210133
    Product Code
    IDZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 4, 2013
    Posted
    June 3, 2013
    Terminated
    July 21, 2017
    Address
    1700 Leider Ln, Buffalo Grove, IL, 60089-6622

    Description

    LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.

    Reason

    An LPC Fine Mesh Cassette failed to stay closed during processing operations.

    Action

    A Medical Device Correction letter dated April 17, 2013 was sent to customers via USPS 1st class mail. The product issue was described and recommended actions were provided. Customers were requested to acknowledge receipt of the letter by fax-back. Customer questions were directed to (847) 405-5413.

    Distribution

    Worldwide distribution: US (nationwide) to states of AZ and KY; and the country of New Zealand.

    Quantity

    20,160 units