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MEDICAL DEVICE RECALLMODERATE
Prismaflex M100 Set
Vantive is recalling the Prismaflex M100 Set due to a potential dislodgement of the deaeration chamber from the control unit.
What to do
Stop using the affected Prismaflex M100 sets and contact your Vantive representative for further instructions.
Why it was recalled
Vantive US Healthcare is recalling the Prismaflex M100 Set due to a potential dislodgement of the deaeration chamber from the control unit. This issue was distributed nationwide.
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 |
|---|---|---|
| PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System | Z-1227-2026 | 07332414064556 |
| OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System | Z-1226-2026 | 07332414102234 |
| PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System | Z-1228-2026 | 07332414090005 |
| PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System | Z-1224-2026 | 00085412954073 |
| PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System | Z-1231-2026 | 07332414111038 |
| PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System | Z-1229-2026 | 07332414069254 |
| PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System | Z-1225-2026 | 00085412917696 |
| PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System | Z-1230-2026 | 07332414069315 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
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Editorial summary by Recall Canary · summary updated 2026-07-04 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification