ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-N
Pending LLM rewrite. Source: FDA_DEVICE Z-1576-2026.
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
- ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
- 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 (5)
- REF:UDI-DI/Lot(Expiration): DC01455550/C:00884450697870/H2600169
- H2628890
- DC21452823-NE5/C:00884450697917/H2990807: DC21453227/C:00884450697948/H2630602
- DC21454035/C:00884450697962/H2628887: DC21455550/C:00884450697979/H2630553
- H2659229
Distribution
Distributed nationwide across the United States.
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