# FDA recall Z-1229-2026

> **VANTIVE US HEALTHCARE LLC** · Class II · device recall initiated 2026-01-06.

## Product

PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System

## Reason for recall

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1229-2026
- **Recalling firm:** VANTIVE US HEALTHCARE LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-06
- **Report date:** 2026-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1229-2026

## Citation

> AI Analytics. FDA recall Z-1229-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1229-2026. Source: US FDA. Licensed CC0.

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