Vantive US Healthcare Recalls Prismaflex ST100 Sets Due to Chamber Dislodgement Risk
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Vantive US Healthcare LLC is recalling 87,436 Prismaflex ST100 Sets because the deaeration chamber may dislodge from the control unit, potentially disrupting dialysis treatment.
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, MedicalDevice.
What Happened
Vantive US Healthcare LLC has initiated a voluntary recall of the Prismaflex ST100 Set. The recall was issued due to a potential issue where the deaeration chamber of the set may dislodge from the Prismaflex Control Unit during operation.
Which Products Are Affected
The recall affects the following medical device:
- Product Name: PRISMAFLEX ST100 SET US (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Product Code: 107636US
- UDI/DI: 00085412954073
- Lot Information: All lots including and manufactured after 24G0072
- Quantity: 87,436 units
- Recall Number: Z-1224-2026
These products were distributed nationwide across the United States.
What You Should Do
The firm initiated the recall process on January 6, 2026, via a notification letter to affected customers. Healthcare facilities and providers should identify any affected stock from the specified lots. For instructions regarding the management of affected units or to report issues, contact Vantive US Healthcare LLC at their headquarters located at 510 Lake Cook Rd, Deerfield, IL 60015-4964.
Why This Matters
A dislodged deaeration chamber can lead to interruptions in dialysis therapy. The FDA has classified this as a Class II recall, indicating that the use of the product may cause temporary or medically reversible adverse health consequences.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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