Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00879-1
Product Name/Description	VASCU-GUARD Peripheral Vascular Patch, 0.8 x 8cm Product Code: VG0108N Lot Number: SP16B05-1119217 Supplied under the Special Access Scheme (SAS)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	1/07/2016
Responsible Entity	Baxter Healthcare Pty Ltd
Reason/Issue	Baxter Healthcare is issuing a recall notice in response to post-marketing reports overseas received for the VASCU-GUARD Peripheral Vascular Patch. To date, Baxter has received four post-marketing reports for the VASCU-GUARD product for intraoperative or post-operative bleeding episodes, which required additional clinical intervention. At this point, it is unknown whether there is any causal relationship between VASCU-GUARD and the reported events. In the interim, Baxter is requesting that customers immediately discontinue the use of the identified product lots until the investigation has concluded.
Recall Action	Recall
Recall Action Instructions	Baxter is advising users to discontinue use, and return all affected stock. This action has been closed-out on 22/03/2018.
Contact Information	1300 789 646 - Baxter Healthcare Customer Service