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Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular re...

FDA Device Recall #Z-0338-2014 — Class II — October 28, 2013

Recall Summary

Recall Number Z-0338-2014
Classification Class II — Moderate risk
Date Initiated October 28, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Synovis Surgical Innovations, Inc.
Location Saint Paul, MN
Product Type Devices
Quantity 6014 units

Product Description

Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0110N VG0110N VG0110N VG0110N VG0110N VG0110N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N

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

Distribution Pattern

Nationwide Distribution.

Lot / Code Information

Lot Numbers: SPCE113-03C0009 SPCE113-03C0067 SPCE113-03C0082 SPCE113-04D0001 SPCE113-04D0003 SPCE113-04D0028 SPCE113-04D0107 SPCE113-05E0032 SPCE113-05E0040 SPCE113-05E0065 SPCE113-05E0092 SPCE113-06F0001 SPCE113-06F0070 SPCE113-06F0071 SPCE113-06F0132 SPCE113-07G0001 SPCE113-07G0047 SPCE113-07G0099 SPCE113-07G0100 SPCE113-07G0116 SPCE113-08H0026 SPCE113-08H0057 SPCE113-FEB0002 SPCE113-FEB0029 SPCE113-JAN0091 SPCE113-JAN0092 SPCE113-JAN0099 SPCE113-JAN0104 SPCE113-JAN0133 SPCE113-03C0001 SPCE113-03C0002 SPCE113-03C0003 SPCE113-03C0022 SPCE113-03C0023 SPCE113-03C0024 SPCE113-03C0047 SPCE113-03C0062 SPCE113-03C0063 SPCE113-03C0064 SPCE113-03C0079 SPCE113-03C0080 SPCE113-03C0081 SPCE113-04D0020 SPCE113-04D0021 SPCE113-04D0032 SPCE113-04D0053 SPCE113-04D0054 SPCE113-04D0063 SPCE113-04D0098 SPCE113-04D0099 SPCE113-04D0108 SPCE113-04D0109 SPCE113-05E0029 SPCE113-05E0030 SPCE113-05E0031 SPCE113-05E0038 SPCE113-05E0039 SPCE113-05E0051 SPCE113-05E0054 SPCE113-05E0066 SPCE113-05E0080 SPCE113-05E0081 SPCE113-05E0082 SPCE113-05E0089 SPCE113-05E0093 SPCE113-06F0023 SPCE113-06F0058 SPCE113-06F0063 SPCE113-06F0064 SPCE113-06F0072 SPCE113-06F0073 SPCE113-06F0129 SPCE113-06F0130 SPCE113-06F0131 SPCE113-07G0003 SPCE113-07G0004 SPCE113-07G0016 SPCE113-07G0041 SPCE113-07G0042 SPCE113-07G0043 SPCE113-07G0044 SPCE113-07G0078 SPCE113-07G0079 SPCE113-07G0095 SPCE113-07G0103 SPCE113-07G0104 SPCE113-07G0111 SPCE113-07G0117 SPCE113-08H0034 SPCE113-08H0053 SPCE113-08H0054 SPCE113-08H0055 SPCE113-08H0056 SPCE113-08H0066 SPCE113-08H0067 SPCE113-08H0068 SPCE113-08H0069 SPCE113-08H0070 SPCE113-08H0081 SPCE113-09I0003 SPCE113-09I0012 SPCE113-09I0021 SPCE113-FEB0006 SPCE113-FEB0007 SPCE113-FEB0031 SPCE113-FEB0032 SPCE113-FEB0062 SPCE113-FEB0063 SPCE113-FEB0064 SPCE113-FEB0065 SPCE113-FEB0066 SPCE113-FEB0074 SPCE113-FEB0076 SPCE113-FEB0077 SPCE113-FEB0078 SPCE113-FEB0104 SPCE113-JAN0035 SPCE113-JAN0086 SPCE113-JAN0087 SPCE113-JAN0089 SPCE113-JAN0090 SPCE113-JAN0093 SPCE113-JAN0101 SPCE113-JAN0102 SPCE113-JAN0103 SPCE113-JAN0119 SPCE113-JAN0120 SPCE113-JAN0134 SPCE113-04D0004 SPCE113-05E0036 SPCE113-05E0037 SPCE113-07G0046 SPCE113-FEB0058 SPCE113-JAN0040 SPCE113-03C0025 SPCE113-03C0026 SPCE113-03C0027 SPCE113-03C0065 SPCE113-03C0066 SPCE113-04D0073 SPCE113-04D0074 SPCE113-04D0111 SPCE113-05E0053 SPCE113-05E0055 SPCE113-05E0067 SPCE113-06F0002 SPCE113-06F0060 SPCE113-06F0074 SPCE113-07G0002 SPCE113-07G0081 SPCE113-07G0083 SPCE113-08H0012 SPCE113-08H0065 SPCE113-FEB0046 SPCE113-FEB0067 SPCE113-FEB0068 SPCE113-FEB0069 SPCE113-JAN0088 SPCE113-JAN0100

Other Recalls from Synovis Surgical Innovations, Inc.

Recall # Classification Product Date
Z-1637-2015 Class I Synovis VASCU-GUARD Peripheral Vascular Patch i... May 2, 2015
Z-0339-2014 Class II Dura Guard, Dural Repair Patch with Apex Proces... Oct 28, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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