Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01226-1
Product Name/Description 9025RHTR ABG Sampling Kit

Lot Number: 0001047501

ARTG Number: 272717
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 26/09/2017
Responsible Entity CareFusion Australia 316 Pty Ltd
Reason/Issue CareFusion have been advised of an issue with a specific lot of 9025RHTR ABG Sampling Kits. These kits should contain a sub-assembly comprised of a 25 Gauge needle, with 1mL syringe, and 3.12 International Units (IU) of Heparin.

An error in manufacturing of one lot of the 9025RHTR ABG Kit(s) has been identified as incorrectly containing a sub-assembly which includes a larger needle (23 Gauge needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.

To date, no reports relating to this issue have been receivedin Australia, and CareFusion is not aware of any report of injury attributed to this defect in Australia.
Recall Action Recall
Recall Action Instructions 1. Discontinue use of and segregate the above identified Lot Numbers of Catalogue Number 9025RHTR ABG Sampling Kit with lot number 0001047501.
2. CareFusion is requesting any impacted inventory be set aside for collection.
3. Users are to Complete the supplied Customer Acknowledgement Form to confirm receipt of this notification and return to CareFusion as directed.
4. CareFusion will then arrange for the pick-up of your affected stock and issue a credit.
This action has been closed out on the 12/09/2018
Contact Information 1800 833 372 - CareFusion Customer Service