Dura Guard — Class II medical device recall Z-0339-2014
Terminated recall by Synovis Surgical Innovations, Inc., reported 2013-11-27, distributed nationwide. Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUAR
| Recall number | Z-0339-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synovis Surgical Innovations, Inc., Saint Paul, MN, United States |
| Recall initiated | 2013-10-28 |
| Classified | 2013-11-18 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2014-06-03 |
| Distributed | Nationwide (US) |
| Quantity | 446 units |
| Lot numbers | SPCE113-03C0004, SPCE113-03C0006, SPCE113-03C0008, SPCE113-03C0069, SPCE113-03C0070, SPCE113-03C0071, SPCE113-03C0072, SPCE113-04D0002, SPCE113-04D0036, SPCE113-04D0047, SPCE113-04D0085, SPCE113-04D0086, SPCE113-04D0092, SPCE113-04D0093, SPCE113-05E0047, SPCE113-05E0048, SPCE113-05E0052, SPCE113-05E0072, SPCE113-05E0073, SPCE113-05E0074, SPCE113-06F0053, SPCE113-06F0054, SPCE113-06F0055, SPCE113-06F0057, SPCE113-06F0138, SPCE113-06F0139, SPCE113-07G0008, SPCE113-07G0072, SPCE113-07G0074, SPCE113-07G0075, SPCE113-07G0077, SPCE113-08H0016, SPCE113-08H0018, SPCE113-08H0019, SPCE113-08H0073, SPCE113-FEB0092, SPCE113-JAN0046, SPCE113-JAN0047, SPCE113-JAN0048, SPCE113-JAN0106 and 2 more |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0339-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.