Vantive US Healthcare Recalls Prismaflex HF1000 Sets Due to Component Dislodgement Risk
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Vantive US Healthcare LLC is recalling over 93,000 Prismaflex HF1000 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 "high" 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 HF1000 Set. The recall was prompted by the discovery of a potential issue where the deaeration chamber of the set may dislodge from the Prismaflex Control Unit during medical procedures.
Which Products Are Affected
The recall involves the following medical device:
- Product Name: PRISMAFLEX HF1000 SET (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Product Code: 107140
- Recall Number: Z-1229-2026
- UDI/DI: 07332414069254
- Lot Information: All lots including and manufactured after 24G0034CA
- Quantity: 93,576 units
- Distribution: Nationwide across the United States
What You Should Do
The firm began notifying customers of the issue via a letter sent on January 6, 2026. Healthcare facilities and providers in possession of the affected lots should follow the specific guidance provided in the manufacturer's notification letter. For additional inquiries, contact Vantive US Healthcare LLC, located at 510 Lake Cook Rd, Deerfield, IL 60015.
Why This Matters
This recall is classified as Class II by the FDA. The potential dislodgement of the deaeration chamber from the control unit during dialysis could lead to treatment interruptions or other safety risks for patients undergoing care.
Source
Information sourced from the FDA (Event ID: 98180).
Original source: FDA Official Notice ↗
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