FDA-Device2019-01-02Class II

GEM Coupler Forceps, GEM4183C, packaged individually.

Baxter Healthcare Corporation
Hazard

Potential presence of rust on Coupler Forceps (GEM4183C).

Sold states
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
Affected count
123 devices
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
GEM Coupler Forceps, GEM4183C, packaged individually.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0680-2019

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