AB ULAX: Medical Device Recall in 2020 - (Recall #: Z-0059-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 4, 2020

Date Posted: October 14, 2020

Recall Number: Z-0059-2021

Event ID: 86417

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.

Status: Terminated

Product Quantity: 1,484,100 units

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated