Recalls / —

—#169008

Product

GEM Coupler Forceps, GEM4183C, packaged individually.

FDA product code

HTD — Forceps

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850

Why it was recalled

Potential presence of rust on Coupler Forceps (GEM4183C).

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

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

Timeline

Recall initiated

2018-11-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #169008. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.