Medical device recalls Moderate risk

Baxter Healthcare Corporation recalls GEM Coupler Forceps, GEM4183C, packaged individually.

Recall date
November 2, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0680-2019
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
Nationwide distribution to CA, FL, GA, KS, LA, MA, MS, NE, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WV. International distribution to United Kingdom, Germany, South Africa, Japan, and Australia

Why it was recalled

Potential presence of rust on Coupler Forceps (GEM4183C).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GEM Coupler Forceps, GEM4183C, packaged individually.

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