Cv Peri-Guard and Vascu-Guard

• • Ongoing Z-0669-2024 FDA Class II ·initiated 6 Dec 2023

  Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

• • Terminated Z-2533-2016 FDA Class II ·initiated 24 Jun 2016

  Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch. Baxter has received reports for intraoperative or postoperative bleeding episodes, which required additional clinical intervention. One report involved a case with a fatal outcome. UPDATE 9/1/2016 Baxter issued a notice retrieving 6 lots of VASCU-GUARD due to the increased postmarketing reports related to intraoperative and postoperative bleeding.

• • Terminated Z-0338-2014 FDA Class II ·initiated 28 Oct 2013

  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

510(k) Number

K983602 ↗

FDA Product Code

DXZ

Device Class

Class II

Regulation

21 CFR Part 870.3470

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Tissue Patch, Tissue Graft

  Class II

  FDA 510(k) K921895 Active Cleared 4 Nov 1992

• Peri-Strips Dry - Staple Line Reinforcement

  Class II

  FDA 510(k) K971048 Active Cleared 9 May 1997

• Vascu-Guard

  Class II

  FDA 510(k) K942010 Active Cleared 7 Jul 1994

• Bvi Sling

  Class II

  FDA 510(k) K002233 Active Cleared 13 Oct 2000

• Peri-Guard Pericardium

  Class II

  FDA 510(k) K961811 Active Cleared 13 Jun 1996

• Peri-Guard, Cv Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc Open recall

  Class II

  FDA 510(k) K983162 Active Cleared 9 Oct 1998

See all devices from Bio-Vascular, Inc. →