FDA-Device2022-06-15Class II

Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

Hazard

Potential for the tip of the electrode to detach during use.

Sold states
Distributed to North Carolina.
Affected count
125 units
Manufactured in
3000 E Sawyer Rd, Republic, MO, United States
Products
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

Official notice

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

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