Reported Nov 27, 2013 · Terminated
Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during…
Synovis Surgical Innovations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synovis Surgical Innovations, Inc. · 2575 University Ave W · Saint Paul, MN · 55114-1073
Is this the product you have?
- Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery
- Product Code
DG0209SNDG0209SNDG0209SNDG0209SNDG0209SNDG0209SNDG0209SNDG0209SNDG0404SNDG0404SNDG0404SNDG0404SNDG0404SNDG0404SNDG0404SNDG0404SNDG0404SNDG0404SNDG0404SNDG0404SNDG0404SNDG0404SNDG0404SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SNDG0608SN
- Lot codes and dates
- Lot Numbers
SPCE113-03C0006SPCE113-04D0002SPCE113-04D0047SPCE113-05E0052SPCE113-05E0072SPCE113-07G0077SPCE113-08H0018SPCE113-08H0073SPCE113-03C0008SPCE113-03C0072SPCE113-04D0036SPCE113-04D0092SPCE113-04D0093SPCE113-05E0047SPCE113-05E0048SPCE113-06F0053SPCE113-06F0054SPCE113-07G0008SPCE113-07G0072SPCE113-08H0016SPCE113-FEB0092SPCE113-JAN0046SPCE113-JAN0106SPCE113-03C0004SPCE113-03C0069SPCE113-03C0070SPCE113-03C0071SPCE113-04D0085SPCE113-04D0086SPCE113-05E0073SPCE113-05E0074SPCE113-06F0055SPCE113-06F0057SPCE113-06F0138SPCE113-06F0139SPCE113-07G0074SPCE113-07G0075SPCE113-08H0019SPCE113-JAN0047SPCE113-JAN0048SPCE113-JAN0109SPCE113-JAN0125
- Lot Numbers
- Amount recalled
- 446 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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