FDA Enforcement
Class II
Ongoing
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Recall: Z-1010-2026
·
Reported January 14, 2026
Enforcement
- Recall Number
- Z-1010-2026
- Event ID
- 98191
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Applied Medical Resources Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 14, 2026
- Initiation Date
- December 11, 2025
- Classification Date
- January 2, 2026
- Address
- 22872 Avenida Empresa, Rancho Santa Margarita, CA, 92688-2650, United States
Description
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Reason
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Code Info
UDI: (01)00607915126582; Lot # 1546141
Distribution
US: MI, CA, ME, OUS: France Great Britain, Germany
Quantity
450 units