BEUDAMED
    FDA Recall 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 · Initiated September 26, 2014

    Recall

    Recall Number
    Z-0039-2018
    Event Number
    78207
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    GDZ
    Status
    Completed
    Root Cause
    Process control
    Initiated
    September 26, 2014
    Posted
    October 16, 2017
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    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.

    Action

    The firm, Teleflex, sent an "Urgent Medical Device Recall 1st Notification" letter dated 09/26/2017 to its customers by FedEx 2-day. The letter described the product, problem and actions to be taken. All affected consignees are instructed to take the following actions: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow us to document your receipt of this letter." If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

    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