Z-0059-2021 Class II Terminated
FDA device recall Z-0059-2021 was initiated by AB ULAX on September 4, 2020 and is designated Class II. 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… The recall status is terminated (terminated February 10, 2023). Affected quantity: 1,484,100 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 14, 2020
- Initiation Date
- September 4, 2020
- Termination Date
- February 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,484,100 units
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Sweden, Taiwan, Hong Kong, and Spain.
Code Information
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