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U.S. Department of Health and Human Services

Class 1 Device Recall VASCUGUARD Pheripheral Vascular Patch

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  Class 1 Device Recall VASCUGUARD Pheripheral Vascular Patch see related information
Date Initiated by Firm May 02, 2015
Date Posted May 29, 2015
Recall Status1 Terminated 3 on February 18, 2016
Recall Number Z-1637-2015
Recall Event ID 71191
510(K)Number K142461  
Product Classification Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
Product Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
Code Information all lot numbers
Recalling Firm/
Manufacturer		 Synovis Surgical Innovations, Inc.
2575 University Ave W
Saint Paul MN 55114-1073
For Additional Information Contact Center for Service
888-229-0001
Manufacturer Reason
for Recall		 Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Baxter, sent an "Urgent Product Recall" letter dated 5/2/2015 via USPS overnight delivery to its customers. The letter identified the affected product, problem and actions to be taken. The customers were instructed to immediately discontinue use and segregate the affected product, locate and remove all affected product from your facility and to return it to Baxter. Customers are to contact Baxter Healthcare Center, 888-229-0001, for Service to arrange for return and credit. In addition, the customers were to complete and return the Customer Reply Form by faxing to 224-270-5457 or emailing to fca@baxter.com. If you have any questions, contact Director, Quality at 651-796-7543 or email: heidi_drafall@baxter.com.
Quantity in Commerce 3,974
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXZ and Original Applicant = Synovis Life Technologies Inc.
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