FDA-Device2026-01-14Class II

Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23

Applied Medical Resources Corp
Hazard

There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.

Sold states
US: MI, CA, ME, OUS: France Great Britain, Germany
Affected count
450 units
Manufactured in
22872 Avenida Empresa, Rancho Santa Margarita, CA, United States
Products
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1010-2026

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