VASCU-GUARD Peripheral Vascular Patch, 0.8 x 8cm 의 리콜

Recall

RC-2016-RN-00879-1

Class I

2016-07-01

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00879-1

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.

Baxter is advising users to discontinue use, and return all affected stock.