PlainRecalls
FDA Devices Moderate Class II Ongoing

GEM Coupler Forceps, GEM4183C, packaged individually.

Reported: January 2, 2019 Initiated: November 2, 2018 #Z-0680-2019

Product Description

GEM Coupler Forceps, GEM4183C, packaged individually.

Reason for Recall

Potential presence of rust on Coupler Forceps (GEM4183C).

Details

Units Affected
123 devices
Distribution
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
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
GEM Coupler Forceps, GEM4183C, packaged individually.. Recalled by Baxter Healthcare Corporation. Units affected: 123 devices.
Why was this product recalled?
Potential presence of rust on Coupler Forceps (GEM4183C).
Which agency issued this recall?
This recall was issued by the FDA Devices on January 2, 2019. Severity: Moderate. Recall number: Z-0680-2019.