Vantive US Healthcare Recalls PRISMAFLEX M150 Sets Due to Deaeration Chamber Issues
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Vantive US Healthcare LLC has initiated a voluntary recall of over 137,000 PRISMAFLEX M150 Sets due to a risk of the deaeration chamber dislodging from the control unit.
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, Devices.
What Happened
Vantive US Healthcare LLC has initiated a voluntary recall of the PRISMAFLEX M150 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. The FDA has classified this as a Class II recall.
Which Products Are Affected
The recall involves approximately 137,576 units distributed nationwide across the United States. Affected products include:
- Product Name: PRISMAFLEX M150 SET (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Product Code: 109990
- UDI/DI: 07332414090005
- Lot Information: All lots including and manufactured after 24F0100CA
- Recall Number: Z-1228-2026
What You Should Do
Vantive US Healthcare LLC began notifying affected customers via a formal letter on January 6, 2026. Healthcare facilities and providers should immediately check their inventory for the specified lot numbers. For additional information or instructions regarding the return of affected units, contact Vantive US Healthcare LLC at their Deerfield, Illinois office located at 510 Lake Cook Rd.
Why This Matters
The dislodgement of the deaeration chamber during medical procedures could lead to therapy interruptions or other clinical complications. A Class II classification indicates that while the probability of serious adverse health consequences is remote, the product may cause temporary or medically reversible health issues.
Source
Information provided by the FDA under event ID 98180.
Original source: FDA Official Notice ↗
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