BEUDAMED
    FDA Enforcement Class II 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 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1446-2013
    Event ID
    64968
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Leica Microsystems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    April 4, 2013
    Classification Date
    June 3, 2013
    Termination Date
    July 21, 2017
    Address
    1700 Leider Ln, N/A, Buffalo Grove, IL, 60089-6622, United States

    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.

    Code Info

    1) Part No.: 14060546848; Batch No.s: 8280-10309, 82801-0310; 2) Part No.: 14060546846; Batch No.s: 1034710114; 3) Part No.: 14060546845; Batch No.s: 1021420914; 4) Part No.: 14060546933; Batch No.s: 82801-0217; 5) Part No.: 14060546932; Batch No.s: 1030730112, 1101110204; 6) Part No.: 14060546852; Batch No.s: 1101910322; 7) Part No.: 14060546850; Batch No.s: 1034710204, 1034710328, 1113910803; 8) Part No.: 14060546847; Batch No.s: 913920827

    Distribution

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

    Quantity

    20,160 units