BEUDAMED
    FDA Enforcement Class II Terminated

    PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15

    Recall: Z-2800-2015 · Reported September 30, 2015

    Enforcement

    Recall Number
    Z-2800-2015
    Event ID
    72038
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zien Medical Technologies, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 30, 2015
    Initiation Date
    August 18, 2015
    Classification Date
    September 21, 2015
    Termination Date
    December 9, 2015
    Address
    2500 S State St, Sted240, Salt Lake City, UT, 84115-3110, United States

    Description

    PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15

    Reason

    Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July 2015. This led to the decision to recall the product.

    Code Info

    Product Code PB-M-10, Lots 140901J-A, 150228PB10, 150509PB10, 150510PB10; Product Code PB-M-11P, Lots 140901J-B, 150227PB11, 150318PB11, 150509PB11, 150510PB11; Product Code PB-M-15, Lots 140901J-C, 150226PB15, 150326PB15, 150511PB15, 150512PB15, 150529PB15.

    Distribution

    Worldwide distribution to U.S. nationwide, Germany and England.

    Quantity

    28,284