BEUDAMED
    FDA Enforcement Class II Completed

    Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

    Recall: Z-0039-2018 · Reported October 25, 2017

    Enforcement

    Recall Number
    Z-0039-2018
    Event ID
    78207
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 25, 2017
    Initiation Date
    September 26, 2014
    Classification Date
    October 19, 2017
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186, United States

    Description

    Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

    Reason

    The knife handles slot depth is out of specification, so blades may not fit on the handles properly.

    Code Info

    a) REF 352950: Lot numbers: D6, J6, E6, F6, G6, H6, I6 b) REF 352953: Lot numbers: I6, B6, E6 c) REF 352951: Lot numbers: I6, J6 d) REF 352957: Lot numbers: A6, B6, B7, K6, L6 e) REF 352952: Lot numbers: H6

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of: Canada, France, Taiwan, Argentina, Australia, S. Korea, Belgium, Singapore, India, Indonesia, Philippines and Thailand.

    Quantity

    6197 units