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Open, Classified

GEM Coupler Forceps, GEM4183C, packaged individually.

FDA Recall Z-0680-2019 · Posted None

Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeHTD
Date Initiated2018-11-02
Product Quantity123 devices

Reason for Recall

Potential presence of rust on Coupler Forceps (GEM4183C).

Firm Action

Synovis Micro Companies Alliance (MCS), Inc. a subsidiary of Baxter International Inc., notified customers on about 11/02/2018 via "Urgent Product Recall letter sent via U.S.P.S., first class mail. Instructions included to review inventory for affected product, arrange for return of all affected product to Synovis MCA, complete and return the provided Baxter customer reply form, and notify customers if the affected product was further distributed. General questions can be directed to Synovia MCA at 800-510-3318 or 205-941-0111 Monday through Friday, between 8:00 am and 5:00 pm Central Time.

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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