Surgical blade instruments recalled for potential assembly defect
Applied Medical Resources is recalling 450 units of Kii Low Profile surgical instruments due to a potential blade obturator assembly defect that could affect surgical performance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall involving a structural assembly defect in a surgical instrument that could impair function during use. No injuries or illnesses have been reported, but this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Applied Medical Resources Corp is recalling 450 units of Kii Low Profile, Bladed Dual Pack surgical instruments (5x55mm, Lot #1546141, UDI 00607915126582). The recall affects units distributed in the United States (Michigan, California, Maine) and internationally (France, Great Britain, Germany).
The instruments are being recalled due to a potential assembly defect in which the blade obturator may extend beyond its intended length after assembly into the cannula and seal housing. This defect could affect the instrument's proper function during surgical use.
This is a Class II recall issued by the U.S. Food and Drug Administration. Healthcare facilities and users of these instruments should verify their inventory for the affected lot number and contact Applied Medical Resources Corp regarding replacement or return instructions.
The recalled product
- Product
- Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
- Manufacturer
- Applied Medical Resources Corp
- Hazard
- assembly-defect
- blade-extension
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: (01)00607915126582
- Lot # 1546141
Distribution
Distributed in 3 states:
- CA
- ME
- MI
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