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