Events

Recall of Pilling Knife Handles

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Teleflex Medical Australia Pty Ltd.

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
    RC-2017-RN-01280-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01280-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Teleflex medical has identified that the slot depth of pilling knife handles are out of specification, so blades may not fit on the handles properly. if a blade does not fit properly, the user may struggle to connect the two pieces, causing them to slip and cut their hand. or, if the blade is not securely connected when the product is used in surgery, the blade could dislodge during use and fall into the body cavity. to date, teleflex medical has not received any reports of patient injuries or deaths relating to this issue.
  • Action
    Teleflex is advising customers to quarantine all affected stock and discontinue use. Teleflex will arrange collection of affected product from impacted customers and apply credit to their accounts.

Device

Pilling Knife Handles
  • Model / Serial
    Pilling Knife HandlesKnife Handle 3 - Straight tip, Straight shaft, 3, 4 7/8" (12.5cm)Knife Handle 3L - Straight tip, Straight shaft, 3L, 8 3/8" (21cm)Knife Handle 3LA - Angled tip, Straight shaft, 3LA, 8 1/8" (20.5cm)Knife Handle 4 - Straight tip, Straight shaft, 4, 5 3/8" (13.5cm)Knife Handle 7 Scalpel - Straight tip, Straight shaft, 7 SCALPEL, 6 3/8" (16.5cm)Multiple Product Codes and Lot NumbersARTG: 94282
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd