Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00350-1
Product Name/Description Thoracentesis/paracentesis kit, Illinois needle aspiration & Jamshidi needle bone marrow

Thoracentesis/paracentesis kit 10/CS - TPK1001
Lot No. (LN): 0000851185, 0000840336, 0000842215, 0000837811

Illinois (TJ) needle aspiration - TIN3015, TIN3018
LN: 0000841213, 0000848061, 0000841215, 0000841212, 0000852078

Jamshidi (TJ) needle bone marrow - TJM4011, TJC6011, TJC3513, TJC4011
LN: 0000852932, 0000843076, 0000853878, 0000841124, 0000851431, 0000850937

ARTG: 120894, 120890, 120892
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 10/03/2017
Responsible Entity CareFusion Australia 316 Pty Ltd
Reason/Issue The manufacturer has received six reports where an open seal of the immediate packaging of devices was identified by customers. This open seal has the potential to compromise the sterility of the device(s). To date, no reports have been received in Australia.

The packaging for the affected product codes were found to have an opening in the seal which maintains the sterility of the device.
The issue of the packaging failure is visually obvious.
Recall Action Recall
Recall Action Instructions Customers are advised to discontinue use of the identified codes for the affected lot numbers. Contact BD to return and if required arrange a replacement or credit.

This action has been closed out on the 08/11/2018.
Contact Information 1800 833 372 - CareFusion Customer Service