Laparoscopic trocars recalled over a potentially extended blade obturator length
Applied Medical Resources is recalling 450 units of the Kii Low Profile Bladed Dual Pack because of the potential for extended length of the blade obturator after assembly.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites an extended blade obturator length after assembly with no stated consequence or reported harm.
Plain-English summary
The Kii Low Profile, Bladed Dual Pack, quantity 1, 5x55mm, REF CTB23, is being recalled by Applied Medical Resources Corp.
The reason given in the enforcement record is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
The record lists 450 units carrying UDI (01)00607915126582, from lot 1546141. Distribution covered Michigan, California and Maine in the United States, and France, Great Britain and Germany outside it. The FDA has classified the action as Class II.
The record describes an assembly dimension outside the intended specification and states no consequence or reported injuries. Facilities should quarantine the affected lot and follow the firm's instructions.
The recalled product
- Product
- Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
- Manufacturer
- Applied Medical Resources Corp
- Category
- Medical Device — Trocar
- Hazard
- dimensional-deviation
- obturator
- laparoscopic
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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