# FDA recall Z-0059-2021

> **AB ULAX** · Class II · device recall initiated 2020-09-04.

## Product

1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage:  Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.

## Reason for recall

Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the closed respiratory circuit during use. If the HME separates, the ventilator circuit may not provide adequate ventilation to the patient, potentially resulting in lack of oxygen leading to hypoxia or death.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Sweden, Taiwan, Hong Kong, and Spain.

## Key facts

- **Recall number:** Z-0059-2021
- **Recalling firm:** AB ULAX
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-04
- **Report date:** 2020-10-14
- **Termination date:** 2023-02-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Motala, N/A, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0059-2021

## Citation

> AI Analytics. FDA recall Z-0059-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0059-2021. Source: US FDA. Licensed CC0.

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