CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A,
Pending LLM rewrite. Source: FDA_DEVICE Z-1575-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
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
- CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K
- 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: CENFP15K/A:00884450199992/H3357122
- CENFP15K/B:00884450725917/H2797565
- CENFP17K/A:00884450200001/H2643728
- H2644554
- H2755843
- H2777866
- H3357123
- CENFP19K/A:00884450200018/H2415318
- H2466455
- H2466456
- H2608337
- H2632772
- H2632921
- H2643525
- H2643729
- H2658246
- H2658395
- H2663614
- H2708827
- H2777850
Distribution
Distributed nationwide across the United States.
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