Recall Z-0059-2021— AB ULAX
Class II · Terminated
Class II FDA medical device recall by AB ULAX, initiated 2020-09-04, terminated 2023-02-10. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- AB ULAX
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-09-04
- Terminated
- 2023-02-10
- Firm location
- Motala, N/A, Sweden
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.