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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00670-1
Product Name/Description FLOSEAL Special Applicator Tips

Product Code: 1502186

Box Lot Number: HA170818

Pouch Lot Numbers: GR338160 (expiry 31 May 2019) and GR338384 (expiry 30 June 2019)

ARTG Number: 167776
(Baxter Healthcare - Haematological concentrate system applicator, endoscopic)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 7/06/2018
Responsible Entity Baxter Healthcare Pty Ltd
Reason/Issue Baxter Healthcare has identified an issue with the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips. The plastic formulation does not present any toxicity or biocompatibility concerns, but does impact the physical characteristics of the blue luer component.

The affected lots of the FLOSEAL malleable applicator tip have been associated with the cracking of the luer upon connection with the syringe. Since the tip is attached to the syringe outside of the surgical field, it is unlikely that plastic fragments would reach the surgical field. Nevertheless, in exceptional cases, detached subvisible particles may be retained in the body and may cause inflammation, or serve as a nidus for bacteria in already contaminated wounds and contribute to allergic reactions.

To date, there have been no reports of serious injury associated with this issue.
Recall Action Recall
Recall Action Instructions Baxter is advising customers to locate and return all units of the affected product. Instructions for return can be found on the Customer Letter.

This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information 1800 BAXTER (1800 229 837) - Baxter Healthcare Customer Service