BEUDAMED
    FDA Recall 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 · Initiated August 18, 2015

    Recall

    Recall Number
    Z-2800-2015
    Event Number
    72038
    Firm
    Zien Medical Technologies, Inc
    FEI Number
    3009756153
    Product Code
    GDX
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 18, 2015
    Posted
    September 21, 2015
    Terminated
    December 9, 2015
    Address
    2500 S State St, Sted240, Salt Lake City, UT, 84115-3110

    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.

    Action

    All consignees have been notified via email with an attached copy of the recall letter. Telephone calls with be made to all customers and distributors that do not respond directly to email notification to ensure compliance to the recall.

    Distribution

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

    Quantity

    28,284