Class 2 Device Recall DuraGuard Dural Repair Patch

• Date Initiated by Firm: October 28, 2013
• Date Posted: November 18, 2013
• Recall Status: Terminated on June 03, 2014
• Recall Number: Z-0339-2014
• Recall Event ID: 66763
• 510(K)Number: K982282
• Product Classification: Dura substitute - Product Code GXQ
• Product: Dura Guard, Dural Repair Patch with Apex Processing.; ; For use as a dura substitute for the closure of dura mater during neurosurgery.; ; Product Code:; ; DG0209SN ; DG0209SN ; DG0209SN ; DG0209SN ; DG0209SN ; DG0209SN ; DG0209SN ; DG0209SN ; DG0404SN ; DG0404SN ; DG0404SN ; DG0404SN ; DG0404SN ; DG0404SN ; DG0404SN ; DG0404SN ; DG0404SN ; DG0404SN ; DG0404SN ; DG0404SN ; DG0404SN ; DG0404SN ; DG0404SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN ; DG0608SN
• Code Information: Lot Numbers: SPCE113-03C0006 SPCE113-04D0002 SPCE113-04D0047 SPCE113-05E0052 SPCE113-05E0072 SPCE113-07G0077 SPCE113-08H0018 SPCE113-08H0073 SPCE113-03C0008 SPCE113-03C0072 SPCE113-04D0036 SPCE113-04D0092 SPCE113-04D0093 SPCE113-05E0047 SPCE113-05E0048 SPCE113-06F0053 SPCE113-06F0054 SPCE113-07G0008 SPCE113-07G0072 SPCE113-08H0016 SPCE113-FEB0092 SPCE113-JAN0046 SPCE113-JAN0106 SPCE113-03C0004 SPCE113-03C0069 SPCE113-03C0070 SPCE113-03C0071 SPCE113-04D0085 SPCE113-04D0086 SPCE113-05E0073 SPCE113-05E0074 SPCE113-06F0055 SPCE113-06F0057 SPCE113-06F0138 SPCE113-06F0139 SPCE113-07G0074 SPCE113-07G0075 SPCE113-08H0019 SPCE113-JAN0047 SPCE113-JAN0048 SPCE113-JAN0109 SPCE113-JAN0125
• Recalling Firm/ Manufacturer: Synovis Surgical Innovations, Inc.; 2575 University Ave W; Saint Paul MN 55114-1073
• For Additional Information Contact: 651-796-7300
• Manufacturer Reason for Recall: Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) shipped in a divided cell shipping
• FDA Determined Cause: Packaging change control
• Action: A customer notification letter dated 10/28/13 was sent to all customers who purchased the Vascu Guard and the Dura Guard. The letter informs the customers of the problem identified and the actions to be taken. Customers with any questions regarding the recall are instructed to contact Customer Service unit at (800) 423-2090. If customers are distributors or if they have have distributed the recalled products to any other health care provider, they are instructed to notify their accounts and provide them with a copy of the recall notification. If customers would like Baxter to perform the recall task for them, then they are instructed to contact Stericycle at 1-866-912-8417.
• Quantity in Commerce: 446 units
• 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 = GXQ and Original Applicant = BIO-VASCULAR, INC.