Vantive Healthcare recalls Prismaflex M100 dialyzer sets due to potential dislodgement of deaeration chamber from control unit. Affected units include all lots manufactured after 24F0077CA.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Vantive Healthcare is recalling Prismaflex M100 dialyzer sets because the deaeration chamber might become dislodged from the control unit. This could cause serious injury during dialysis treatments if not fixed.
The deaeration chamber in the dialyzer set could become loose or dislodged from the control unit during use. This dislodgement might lead to serious injury if it causes a blockage or malfunction in the dialysis system.
Patients using hemodialysis treatments with the Prismaflex M100 dialyzer set are most at risk. The recall affects all units manufactured after 24F0077CA.
Check for the product code 106697 on the dialyzer set. Affected units include all lots manufactured after 24F0077CA and have the UDI/DI 07332414064556.
Look for the product code 106697 and UDI/DI 07332414064556 on the dialyzer set.
The deaeration chamber could become dislodged from the control unit, potentially causing serious injury during dialysis.
All Prismaflex M100 dialyzer sets with product code 106697 manufactured after 24F0077CA and having UDI/DI 07332414064556.
The recall does not require immediate stop use; however, affected units should be checked for dislodgement risk.
We’ve drafted a message you can send Vantive Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1227-2026 — Vantive Healthcare Vantive Healthcare Hello, I own a Vantive Healthcare that is covered by recall Z-1227-2026 from Vantive Healthcare. 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.
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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.