FDA recall Z-1250-2022

ROi CPS LLC · Class II · device

Product

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

Distributed to North Carolina.

Key facts

Status: Terminated
Initiation date: 2022-05-03
Report date: 2022-06-15
Termination date: 2024-05-31
Voluntary/Mandated: Voluntary: Firm initiated
Location: Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1250-2022