Vascu Guard — Class II medical device recall Z-0338-2014
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-0338-2014 |
|---|---|
| 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 | 6,014 units |
| Lot numbers | SPCE113-03C0001, SPCE113-03C0002, SPCE113-03C0003, SPCE113-03C0009, SPCE113-03C0022, SPCE113-03C0023, SPCE113-03C0024, SPCE113-03C0025, SPCE113-03C0026, SPCE113-03C0027, SPCE113-03C0047, SPCE113-03C0062, SPCE113-03C0063, SPCE113-03C0064, SPCE113-03C0065, SPCE113-03C0066, SPCE113-03C0067, SPCE113-03C0079, SPCE113-03C0080, SPCE113-03C0081, SPCE113-03C0082, SPCE113-04D0001, SPCE113-04D0003, SPCE113-04D0004, SPCE113-04D0020, SPCE113-04D0021, SPCE113-04D0028, SPCE113-04D0032, SPCE113-04D0053, SPCE113-04D0054, SPCE113-04D0063, SPCE113-04D0073, SPCE113-04D0074, SPCE113-04D0098, SPCE113-04D0099, SPCE113-04D0107, SPCE113-04D0108, SPCE113-04D0109, SPCE113-04D0111, SPCE113-05E0029 and 119 more |
Product
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
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-0338-2014. 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.