Recall Z-0680-2019 ยท HTD Forceps
Baxter Healthcare Corporation
GEM Coupler Forceps, GEM4183C, packaged individually.
| Date | Nov 2, 2018 |
| Status | Open, Classified |
| Reason | Potential presence of rust on Coupler Forceps (GEM4183C). |
| Root cause | Process control |
| 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 Tim |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.