GEM Coupler Forceps, GEM4183C, packaged individually.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- November 2, 2018
- Recall Number
- Z-0680-2019
- Quantity
- 123 devices
- Firm Location
- Deerfield, IL
Reason for Recall
Potential presence of rust on Coupler Forceps (GEM4183C).
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
Lot / Code Info
Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850
Root Cause
Process control
Action Taken
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.