Vantive US Healthcare Recalls Prismaflex ST150 Sets Due to Chamber Dislodgement Risk
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Vantive US Healthcare LLC is recalling 264,040 Prismaflex ST150 Sets because the deaeration chamber may dislodge from the control unit, potentially impacting dialysis procedures.
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.
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What Happened
Vantive US Healthcare LLC has initiated a voluntary recall of the Prismaflex ST150 Set. The recall was prompted by the discovery of a potential mechanical issue where the deaeration chamber of the set may dislodge from the Prismaflex Control Unit during operation.
Which Products Are Affected
The recall involves the following medical device:
- Product Name: PRISMAFLEX ST150 SET US (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Product Code: 107640US
- UDI/DI: 00085412917696
- Lot Information: All lots including and manufactured after 24F0085
- Quantity: 264,040 units
- Distribution: Nationwide across the United States
What You Should Do
Vantive US Healthcare LLC initiated the recall process on January 6, 2026, via a notification letter to affected customers. Healthcare facilities and providers currently using these sets should review their inventory for the affected lot numbers. For specific instructions regarding the continued use or return of these devices, contact Vantive US Healthcare LLC at their headquarters in Deerfield, Illinois.
Why This Matters
This recall is classified as a Class II event by the FDA. The dislodgement of the deaeration chamber from the control unit could lead to interruptions in dialysis treatment or other procedural complications, though the probability of serious adverse health consequences is considered remote.
Source
Information provided by the FDA under Recall Number Z-1225-2026.
Original source: FDA Official Notice ↗
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