Z-0680-2019Class II

GEM Coupler Forceps, GEM4183C, packaged individually

Name: Z-0680-2019 GEM Coupler Forceps, GEM4183C, packaged individually
Creator: Baxter Healthcare Corporation
Published: 2018-11-02
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2018-11-02 / Open, Classified / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of GEM Coupler Forceps, GEM4183C, packaged individually on 2018-11-02. FDA classified it as Class II and gives the reason as "Potential presence of rust on Coupler Forceps (GEM4183C)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0680-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-11-02
Posted: 2018-12-22
Recalling firm: Baxter Healthcare Corporation
Product: GEM Coupler Forceps, GEM4183C, packaged individually.
Product code: HTD Forceps
Reason for recall: Potential presence of rust on Coupler Forceps (GEM4183C).
Root cause tag: manufacturing process
FDA 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 in commerce: 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
Product codes and lots: Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0680-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0680-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-01-02	2018-12-22

Product code HTD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)