Vantive US Healthcare Recalls Prismaflex TPE2000 Sets Due to Component Dislodgement Risk
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Vantive US Healthcare LLC has issued a voluntary recall for 13,760 Prismaflex TPE2000 Sets because the deaeration chamber may dislodge from the control unit during use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Vantive US Healthcare LLC has initiated a voluntary recall of the Prismaflex TPE2000 Set. The recall was prompted by the discovery of a potential defect where the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit. This issue was officially classified by the FDA as a Class II recall on February 2, 2026.
Which Products Are Affected
The recall involves medical devices distributed nationwide across the United States. The following specific product is affected:
- Product Name: PRISMAFLEX TPE2000 SET (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Product Code: 114093
- UDI/DI: 07332414111038
- Affected Lots: All lots including and manufactured after 24J0106
- Quantity: 13,760 units
- Recall Number: Z-1231-2026
What You Should Do
Vantive US Healthcare LLC notified affected customers via a formal letter initiated on January 6, 2026. Healthcare providers and facilities in possession of these sets should review their inventory for the affected lot numbers. For further instructions regarding the return or management of these units, contact Vantive US Healthcare LLC at their Deerfield, Illinois headquarters.
Why This Matters
The dislodgement of the deaeration chamber from the control unit can disrupt the dialysis process. While classified as a Class II recall, the defect represents a potential risk to patient safety and the integrity of the medical procedure.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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