Recall Z-0939-2021— Baxter Healthcare Corporation

Name: FDA recall Z-0939-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-28

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2020-12-28. It names one FDA 510(k) clearance: K191252. Product: FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.. Reason: Potential for the battery to lose its ability to be recharged..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2020-12-28
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K191252 — Gem FlowCoupler SystemBaxter/ Synovis Micro Companies Alliance, Inc.·cleared 2019-07-09

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

FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.

Reason for recall

Potential for the battery to lose its ability to be recharged.

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