The Recall Desk

FDA (Devices) recall action 66763

Synovis Surgical Innovations, Inc. recalled 2 products on 2013-11-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-11-27
Critical
0
Units
6,460

Why these products were 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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2013-11-27

    Synovis Recalls Dura-Guard and Vascu-Guard Patches Due to Shipping Errors

    Synovis is recalling Dura-Guard and Vascu-Guard patches because specific units were shipped in divided cell configurations with a specific revision of the Instructions for Use.

    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: DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0404SN DG040
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-27

    Synovis Recalls Vascu Guard and Dura-Guard Patches Due to Shipping Configuration Issues

    Synovis is recalling Vascu Guard and Dura-Guard patches because specific fluid ounce units shipped in divided cell configurations with a specific revision of the Instructions for Use.

    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 VG010
    Category
    Distribution
    0 states