Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during n
FDA device recall Z-0339-2014 · posted 2013-11-18 · Terminated
Recall details
- Recalling firm
- Synovis Surgical Innovations, Inc.
- 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
- Action taken
- 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 recall task for them, then they are instructed to contact Stericycle at 1-866-912-8417.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- GXQ
- Quantity affected
- 446 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-10-28
- Date posted
- 2013-11-18
- Date terminated
- 2014-06-03
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DURA-GUARD - DURAL REPAIR PATCH (K982282) | Bio-Vascular, Inc. | 1998-07-30 |