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Applied Medical Resources Corp: Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23

Medical DevicesSource: FDA (device) · Date: 2026-01-14

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Applied Medical Resources Corp
Product
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Reason / hazard
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Classification
Class II
Status
Ongoing
Distribution / sold at
US: MI, CA, ME, OUS: France Great Britain, Germany
Recall initiated
2025-12-11
Code info
UDI: (01)00607915126582; Lot # 1546141
Product quantity
450 units
Voluntary mandated
Voluntary: Firm initiated
City
Rancho Santa Margarita
State
CA
Country
United States
Event id
98191
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