FDA Device recall Z-0339-2014
Dura Guard, Dural Repair Patch with Apex Processing
- FDA Device
- Class II
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class II recall of Dura Guard, Dural Repair Patch with Apex Processing by Synovis Surgical Innovations, citing 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 reca….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0339-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-28 |
| Published | 2013-11-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synovis Surgical Innovations |
| Distribution | US |
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
Reason
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
Identifiers
| code_info | Lot Numbers: SPCE113-03C0006 SPCE113-04D0002 SPCE113-04D0047 SPCE113-05E0052 SPCE113-05E0072 SPCE113-07G0077 S…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0339-2014%22
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