AB ULAX 1500 Flex Heat and Moisture Exchanger Recall for Disconnection Risk
AB ULAX is recalling 1500 Flex Heat and Moisture Exchangers because they may disconnect from the respiratory circuit, potentially causing hypoxia or death.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect can potentially result in hypoxia or death, which aligns with the rubric criteria for a Severe (4) rating involving significant injury or death reports.
Plain-English summary
AB ULAX is recalling approximately 1,484,100 units of the 1500 Flex Heat and Moisture Exchanger (Catalog Reference 150). These devices are used to enhance humidification for ventilator-dependent and non-ventilator-dependent patients in critical care, home care, and anesthesia settings.
The recall was initiated after the firm received six 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 a lack of oxygen leading to hypoxia or death.
The affected units were distributed worldwide, including nationwide in the United States and in Sweden, Taiwan, Hong Kong, and Spain. The recall covers specific lots manufactured between September 2018 and June 2020, identified by SAP codes 109381602 and 109381603. Users should check their device lot numbers against the recall list and contact AB ULAX for instructions on replacement or return.
The recalled product
- 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.
- Manufacturer
- AB ULAX
- Affected units
- 1,484,100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- SAP 109381602
- Lots 2019-12-20 2020-04-30 2020-05-15 2020-05-20 2020-06-15 2020-06-30
Distribution
Distributed nationwide across the United States.
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