[pending] Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CT
Pending LLM rewrite. Source: FDA_DEVICE Z-0485-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
The recalled product
- Product
- Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
- Manufacturer
- Covidien, LP
- Category
- Medical Device — Devices
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 (7)
- CFN: SIGSDL45CTVT
- UDI-DIs: (1) 20884521741840
- (2) 10884521741843
- Lot numbers: N5F1971Y
- N5F1723Y
- N5D1858UY
- N5B1134UY
Distribution
Distributed nationwide across the United States.
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