Recall Z-1019-2022— Baxter Healthcare Corporation

Name: FDA recall Z-1019-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-01

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-04-01. It names one FDA 510(k) clearance: K981624. Product: Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.. Reason: There is a potential for foreign matter..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-04-01
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K981624 — FLO-THRUBio-Vascular, Inc.·cleared 1998-08-04

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

Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.

Reason for recall

There is a potential for foreign matter.

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