Events

Recall of DuraGuard Dural Repair Patch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synovis Surgical Innovations, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66763
  • Event Risk Class
    Class 2
  • Event Number
    Z-0339-2014
  • Event Initiated Date
    2013-10-28
  • Event Date Posted
    2013-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123332
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dura substitute - Product Code GXQ
  • 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.
  • 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 recall task for them, then they are instructed to contact Stericycle at 1-866-912-8417.

Device

DuraGuard Dural Repair Patch
  • Model / Serial
    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 Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    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 || DG0404SN || DG0404SN || DG0404SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN
  • Manufacturer
    Synovis Surgical Innovations, Inc.

Manufacturer

Synovis Surgical Innovations, Inc.
  • Manufacturer Address
    Synovis Surgical Innovations, Inc., 2575 University Ave W, Saint Paul MN 55114-1073
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA