Dura Guard recall
Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. Product Code…
Why was Dura Guard 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Synovis Surgical Innovations, Inc.
- Quantity
- 446 units
- Distribution
- Nationwide Distribution.
- Recall date
- November 27, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)