FDAHealthDecember 11, 2025
Applied Medical Resources Corp — Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
⚠️ There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Is this relevant to me?
- Geography
- US, MI, CA, ME
- Source agency
- FDA
- Category
- Health
- Published
- December 11, 2025
US: MI, CA, ME, OUS: France Great Britain, Germany
What's affected?
- Product
- Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
- Lot code
- 1546141
Additional details
UDI: (01)00607915126582; Lot # 1546141
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 450 units.
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