Vantive US Healthcare Recalls Prismaflex HF1000 Sets Due to Component Dislodgement Risk

Source: FDA · United States

According to the U.S. Census Bureau's American Community Survey (ACS) 5-year estimates, the CDC PLACES population-level health analysis, and the CMS Hospital Compare quality data, Areazine publishes editorial articles drawing on more than 19,000 U.S. city profiles. See our methodology for full source attribution and refresh cadence.

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 February 18, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, MedicalDevices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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 ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Vantive US Healthcare LLC is recalling over 93,000 Prismaflex HF1000 Sets because the deaeration chamber may dislodge from the control unit during use.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.