[pending] Merit Medical , Custom Manifold Kit REF: K09-13203A
Pending LLM rewrite. Source: FDA_DEVICE Z-1127-2026.
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
Inflation device handle may detach from the syringe during procedure.
The recalled product
- Product
- Merit Medical , Custom Manifold Kit REF: K09-13203A
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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