Z-0680-2019 Class II Ongoing
FDA device recall Z-0680-2019 was initiated by Baxter Healthcare Corporation on Nov 2, 2018 and is designated Class II. Reason for recall: Potential presence of rust on Coupler Forceps (GEM4183C). The recall status is ongoing. Affected quantity: 123 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 2, 2019
- Initiation Date
- Nov 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123 devices
Product Description
GEM Coupler Forceps, GEM4183C, packaged individually.
Reason for Recall
Potential presence of rust on Coupler Forceps (GEM4183C).
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
Code Information
Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0680-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026