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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 450
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
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