AB ULAX: 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.

Recall number

Z-0059-2021

Recalling firm

AB ULAX

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.

Status

Terminated

Initiated

2020-09-04

Posted

not on file

Terminated

2023-02-10

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.

Root cause

Process control

Action

The firm distributed customer letters dated September 4, 2020, which informed customers of the product issue. Distributors were asked to inform customers of the recall. End users were asked to do the following: Inventory that is Currently In-Use: 1. Please evaluate any currently ventilated patient who may have such a device (any BALLARD Heat Moisture Exchanger (HME) 150) in their airway circuit, to determine if they belong to any of the impacted product lots. 2. If any of your patient(s) do have a potentially impacted device in their airway circuit, you must replace such device with a commercially available alternative as soon as possible. Due to the potential for brain damage or death if a circuit interruption were not noticed for about 4 minutes, this is a critical instruction. If, despite this instruction and at your own discretion , you elect still not to do so, then you must check carefully to ensure that both ends of the device are seated very firmly within the circuit; consider taping the device in place at both ends to avoid any potential for disconnections; and ensure that all alarms are working, monitored and addressed immediately if indicated. 3. Please complete the attached End-User Product Recall Response Form and return a copy of the form by email to: Avanos3250@stericycle.com or fax: (888) 229-0320. 4. Once the form is received, a representative will contact you to facilitate return of impacted BALLARD Heat Moisture Exchanger (HME) 150 . 5. Avanos will manage the return of the impacted BALLARD Heat Moisture Exchanger (HME) 150. Please respond within five (5) business days of receipt of this letter. Inventory Already Consumed 6. Please complete the attached End-User Product Recall Response Form (Attachment 1) and select the appropriate box to indicate that you have no inventory of impacted products. 7. Please return this form to Avanos by either email: Avanos3250@stericycle.com or fax: (888)

Quantity

1,484,100 units

Distribution

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

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

BYD

Firm FEI

3004030908

Firm city

Motala

Firm state

not on file

Firm country

Sweden

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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