CentrosFLO Hemodialysis Catheters
Merit Medical recalls CentrosFLO Hemodialysis Catheters over sheath introducer defect that may cause hemorrhage and other serious complications.
Do not use the affected CentrosFLO Hemodialysis Catheters. Contact Merit Medical Systems immediately to arrange for return and replacement of the product. Follow the instructions provided by the firm for safe handling and disposal.
Why it was recalled
Merit Medical Systems is recalling CentrosFLO Hemodialysis Catheters due to a design defect in the 16F dual-valved splittable sheath introducer, which may not split as intended. This can result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, and loss of vessel for future vascular access. The recall affects a range of sizes and pack formats; the full list of affected REF codes is available on the FDA recall detail page.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Recall # | UDI-DI |
|---|---|---|
| ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C | Z-1576-2026 | 00884450697870, 00884450697900, 00884450697894, 00884450697924, 00884450697917, 00884450697948, 00884450697962, 00884450697979 |
| 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, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D | Z-1575-2026 | 00884450199992, 00884450725917, 00884450200001, 00884450200018, 00884450200025, 00884450200056, 00884450276068, 00884450820766, 00884450200063, 00884450276082, 00884450295526, 00884450820773, 00884450276105 |
| 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B | Z-1577-2026 | 00884450522196 |
| BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A | Z-1579-2026 | 00884450793206, 00884450793213, 00884450840733, 00884450786215, 00884450835326, 00884450786253, 00884450835333, 00884450793220, 00884450840740, 00884450793237, 00884450835340, 00884450793244, 00884450840757, 00884450793251, 00884450840764, 00884450792353, 00884450840771, 00884450793268, 00884450793282, 00884450793299 |
| DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A | Z-1578-2026 | 00884450794524, 00884450794548, 00884450786130, 00884450794555, 00884450786161, 00884450794562, 00884450794579, 00884450794586, 00884450794609, 00884450794623, 00884450794630, 00884450794647, 00884450794661, 00884450786178, 00884450794678, 00884450786185, 00884450794692, 00884450794708, 00884450794715, 00884450842249 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Merit Medical Systems, Inc.
Editorial summary by Recall Canary · summary updated 2026-09-07 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification