Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106

FDA device recall Z-2533-2016 · posted 2016-08-12 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch. Baxter has received reports for intraoperative or postoperative bleeding episodes, which required additional clinical intervention. One report involved a case with a fatal outcome. UPDATE 9/1/2016 Baxter issued a notice retrieving 6 lots of VASCU-GUARD due to the increased postmarketing reports related to intraoperative and postoperative bleeding.

Action taken

Baxter sent a Safety Alert to customers via USPS overnight delivery beginning 6/24/2016. The letter told of the reported adverse events, asked for product that product immediately be discontinued from use, to segregate/quarantine all affected lots, and to return the enclosed customer reply form. General questions regarding the Safety Alert should be directed to Baxter Product Surveillance at 1-800-437-5176, between 8:00 am - 5:00 pm Central Time Monday thru Friday. Clinical inquiries can be directed to Baxter's Medical information at 1-800-933-0303, Monday thru Friday 8:00 am - 5:00 pm central time. UPDATE 9/1/2016 Baxter issued an Urgent Product Recall letter beginning 9/1/2016. This letter explained the issue and identified affected product that was to be removed from the consignee and returned to Baxter. Customer is to contact Baxter Healthcare Center for Service to arrange for return and credit. This can be done at 888-229-0001 Monday thru Friday 7:00 am - 6:00 pm Central Time. General questions regarding the recall can be addressed to Baxter Product Surveillance at 800-437-5179 Monday thru Friday, 8:00 am - 5:00 pm Central Time.

Root cause

Under Investigation by firm

Status

Terminated

Product code

DXZ

Quantity affected

32,763 eaches UPDATE 9/1/2016 2,042 eaches

Distribution

Nationwide including Puerto Rico, and outside the US to include: Australia, Austria, Finland, Germany, Greece, Ireland, Italy, the Netherlands, Norway, Poland, Saudi Arabia, South Korea, Spain, Sweden

Date initiated

2016-06-24

Date posted

2016-08-12

Date terminated

2017-06-23

Location

Deerfield, IL

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