Recall Z-0339-2014 ยท GXQ Dura Substitute
Synovis Surgical Innovations, Inc.
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 DG
| Date | Nov 18, 2013 (initiated Oct 28, 2013) |
| Status | Terminated |
| 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 |
| Root cause | Packaging change control |
| Action | A customer notification letter dated 10/28/13 was sent to all customers who purchased the Vascu Guard and the Dura Guard. The letter informs the customers of the problem identified and the actions to be taken. Customers with any questions regarding the recall are instructed to contact Customer Service unit at (800) 423-2090. If customers are distributors or if they have have distributed the recalled products to any other health care provider, they are instructed to notify their accounts and provide them with a copy of the recall notification. If customers would like Baxter to perform the re |
| Quantity | 446 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982282 | DURA-GUARD - DURAL REPAIR PATCH Bio-Vascular, Inc., Jul 30, 1998 |