Z-0059-2021Class II

1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 -

Name: Z-0059-2021 1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 -
Creator: Ab Ulax
Published: 2020-09-04
License: https://open.fda.gov/license/

AB Ulax / initiated 2020-09-04 / Terminated / root cause: manufacturing process

FDA source

AB ULAX began a recall of 1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of... on 2020-09-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0059-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-04
Posted: 2020-10-06
Terminated: 2023-02-10
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.
Product code: BYD Condenser, Heat And Moisture (Artificial Nose)
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.
Root cause tag: manufacturing process
FDA 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: [email protected] 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: [email protected] or fax: (888)
Quantity in commerce: 1,484,100 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Sweden, Taiwan, Hong Kong, and Spain.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0059-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0059-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-06

Product code BYD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)