Recall Z-1686-2020— Baxter Healthcare Corporation

Name: FDA recall Z-1686-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-05

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2020-03-05, terminated 2021-08-02. It names one FDA 510(k) clearance: K861985. Product: GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.. Reason: The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device.

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-03-05
Terminated: 2021-08-02
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K861985 — 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)3M Company·cleared 1986-12-04

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

GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.

Reason for recall

The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device

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