Z-1250-2022 Class II Terminated
FDA device recall Z-1250-2022 was initiated by ROi CPS LLC on May 3, 2022 and is designated Class II. Reason for recall: Potential for the tip of the electrode to detach during use. The recall status is terminated (terminated May 31, 2024). Affected quantity: 125 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 15, 2022
- Initiation Date
- May 3, 2022
- Termination Date
- May 31, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125 units
Product Description
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
Reason for Recall
Potential for the tip of the electrode to detach during use.
Distribution Pattern
Distributed to North Carolina.
Code Information
Catalog No. 60-5274-944; Item Number: 800214007; Model Number: GS00367G; UDI/DI: 10194717101024; Lot Numbers: 88207G (Exp. Date: 05/11/2023), 88396G (Exp. Date: 05/26/2023), 88472G (Exp. Date: 06/02/2023), 88965G (Exp. Date: 07/02/2023), 91105 (Exp. Date: 01/07/2024)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1250-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026