[pending] 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Pending LLM rewrite. Source: FDA_DEVICE Z-1577-2026.
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
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
The recalled product
- Product
- 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
- Manufacturer
- Merit Medical Systems, Inc.
- 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 (20)
- REF:UDI-DI/Lot: FCL-174-00/B:00884450522196/I2362705
- I2370091
- I2370711
- I2370712
- I2377840
- I2377841
- I2391548
- I2397290
- I2415120
- I2417400
- I2417401
- I2417402
- I2428656
- I2428657
- I2428658
- I2428659
- I2469204
- I2469205
- I2469206
- I2469207
Distribution
Distributed nationwide across the United States.
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