Device product
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Z-1010-2026
Product summary
- Event
- Event 98191
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 450 units
- Official record key
device-enforcement:Z-1010-2026
Official wording
Reason: There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Code information: UDI: (01)00607915126582; Lot # 1546141
Distribution pattern: US: MI, CA, ME, OUS: France Great Britain, Germany
Derived failure modes
-
Unknown
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.