FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: GEM Coupler Forceps, GEM4183C, packaged individually.
- Recall number
- Z-0680-2019
- Recalling firm
- Baxter Healthcare Corporation
- Product
- GEM Coupler Forceps, GEM4183C, packaged individually.
- Status
- Open, Classified
- Initiated
- 2018-11-02
- Posted
- not on file
- Terminated
- not on file
- 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 Time.
- 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
- Lot, serial or model codes
- Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTD
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28