Events

Recall of Pilling Knife Handle

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78207
  • Event Risk Class
    Class 2
  • Event Number
    Z-0039-2018
  • Event Date Posted
    2017-10-16
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158889
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Handle, scalpel - Product Code GDZ
  • 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 recalls@teleflex.com. 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 recalls@teleflex.com. 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.

Device

Pilling Knife Handle
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Canada, France, Taiwan, Argentina, Australia, S. Korea, Belgium, Singapore, India, Indonesia, Philippines and Thailand.
  • Product 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.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA