Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01036-1
Product Name/Description	TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI GUARD (Xenograft)
Recall Action Level	Wholesale
Recall Action Classification	Class II
Recall Action Commencement Date	14/10/2013
Responsible Entity	Baxter Healthcare Pty Ltd
Reason/Issue	There is a possibility of packaging leakage for the TISSUE-GUARD Family of Products- VASCU-GUARD, DURA-GUARD, PERI-GUARD, and SUPPLE PERI-GUARD. These products are packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile. Leakage can occur as a result of damage during shipment and can be identified by an unsealed container or by highly visible evidence of water damage to the packaging, Instructions for Use, box, label, and/or - surrounding products in the shipping container..
Recall Action	Recall
Recall Action Instructions	Baxter is requesting their customers to locate all affected product and return for credit.
Contact Information	02 8845 1501 - Baxter Healthcare