FDA Device recall Z-0059-2021
1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humi…
- FDA Device
- Class II
- terminated
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class II recall of 1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humi… by Ab Ulax, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0059-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-04 |
| Published | 2020-10-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ab Ulax |
| Distribution | US |
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.
Identifiers
| code_info | SAP 109381602, Lots: 2018-09-25 2018-11-20 2018-12-10 2018-12-20 2019-01-03 2019-02-20 2019-03-20 2019-04-15 20…SAP 109381602, Lots: 2018-09-25 2018-11-20 2018-12-10 2018-12-20 2019-01-03 2019-02-20 2019-03-20 2019-04-15 2019-05-30 2019-06-25 2019-08- 15 2019-09-05 2019- 11-05 2019-11-25 *** SAP 109381603, Lots 2019-12-20 2020-04-30 2020-05-15 2020-05-20 2020-06-15 2020-06-30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0059-2021%22
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