Vantive US Healthcare recalls Prismaflex TPE2000 Set (Product Code 114093) due to potential dislodgement of deaeration chamber from control unit. Affected units include all lots manufactured after 24J0106.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Vantive US Healthcare is recalling Prismaflex TPE2000 Set dialyzers because the deaeration chamber might detach from the control unit. This could cause serious complications during hemodialysis treatments if the chamber becomes dislodged.
The deaeration chamber in the Prismaflex Set could become dislodged from the control unit during use. If this happens, it might cause a blockage or malfunction in the dialysis system, potentially leading to serious complications for patients.
Hemodialysis patients using the Prismaflex TPE2000 Set with Product Code 114093 are most at risk. Healthcare providers who use this equipment for dialysis treatments may also be affected.
Check for the Product Code 114093 on the Prismaflex TPE2000 Set. Affected units were manufactured after 24J0106 and include all lots with UDI/DI 07332414111038.
Look for Product Code 114093 on the Prismaflex TPE2000 Set to confirm if it's affected.
The recall is for potential dislodgement of the deaeration chamber from the control unit, which could cause serious complications during dialysis. However, the remedy is not specified in the record.
The recall record does not specify any remedy steps. Check the Product Code 114093 to see if your unit is affected.
Affected units were manufactured after 24J0106 and include all lots with UDI/DI 07332414111038.
We’ve drafted a message you can send Vantive US Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1231-2026 — Vantive US Healthcare Vantive US Healthcare Hello, I own a Vantive US Healthcare that is covered by recall Z-1231-2026 from Vantive US 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.
