Merit Medical Systems recalls CentrosFLO Hemodialysis Catheters with design defect that may not split properly, leading to bleeding, foreign bodies, or procedure delays. Affected models include CENFP15K/A through CENFT31K/D.
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.
Merit Medical Systems is recalling CentrosFLO Hemodialysis Catheters due to a design defect that may prevent the sheath from splitting as intended. This can cause bleeding, foreign bodies, procedure delays, or other complications during dialysis treatments.
The catheter's dual-valved splittable sheath introducer has a design defect that may not split properly during use. This can lead to bleeding, foreign bodies in the bloodstream, procedure delays, or impaired catheter function, which may cause serious complications during dialysis.
Patients receiving hemodialysis treatments are most at risk. The affected catheters were sold to healthcare facilities and patients who use them for dialysis.
Check the product reference codes (REF) listed in the recall notice. Affected models include CENFP15K/A, CENFP15K/B, CENFP17K/A, and other variants up to CENFT31K/D. The specific lot numbers and UDI-DI codes are also listed in the recall notice.
Look for the product reference codes (REF) listed in the recall notice, such as CENFP15K/A through CENFT31K/D.
Contact Merit Medical Systems directly for further assistance with the recall.
The dual-valved splittable sheath introducer may not split as intended, which can lead to bleeding, foreign bodies, procedure delays, or impaired catheter function.
Check the product reference codes (REF) listed in the recall notice, such as CENFP15K/A through CENFT31K/D. The specific lot numbers and UDI-DI codes are also listed in the recall notice.
Contact Merit Medical Systems directly for further assistance with the recall.
We’ve drafted a message you can send Merit Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1575-2026 — Merit Medical Systems Merit Medical Systems Hello, I own a Merit Medical Systems that is covered by recall Z-1575-2026 from Merit Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
