Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01280-1
Product Name/Description	Pilling Knife Handles Knife 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 Numbers ARTG: 94282
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	9/10/2017
Responsible Entity	Teleflex Medical Australia Pty Ltd
Reason/Issue	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.
Recall Action	Recall
Recall Action Instructions	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. This action has been closed out on 19/09/2018
Contact Information	1300 360 226 - Teleflex Medical Australia