Recall Z-0680-2019— Baxter Healthcare Corporation

Name: FDA recall Z-0680-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-02

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2018-11-02. FDA's recall record names no specific 510(k) clearance for this event. Product: GEM Coupler Forceps, GEM4183C, packaged individually.. Reason: Potential presence of rust on Coupler Forceps (GEM4183C)..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2018-11-02
Firm location: Deerfield, IL, United States

Product description

GEM Coupler Forceps, GEM4183C, packaged individually.

Reason for recall

Potential presence of rust on Coupler Forceps (GEM4183C).

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