Recall Z-0669-2024— Baxter Healthcare Corporation

Name: FDA recall Z-0669-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-06

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2023-12-06. It names one FDA 510(k) clearance: K983602. Product: Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBAL. Reason: 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)..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-12-06
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K983602 — CV PERI-GUARD AND VASCU-GUARDBio-Vascular, Inc.·cleared 1998-11-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBAL

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.