Class 2 Device Recall Halyard, Ballard, Avanos 1500 Flex Heat and Moisture Exchanger

• Date Initiated by Firm: September 04, 2020
• Create Date: October 06, 2020
• Recall Status: Terminated on February 10, 2023
• Recall Number: Z-0059-2021
• Recall Event ID: 86417
• Product Classification: Condenser, heat and moisture (artificial nose) - Product Code BYD
• 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.
• 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
• Recalling Firm/ Manufacturer: AB ULAX ; Merkuriusgatan 8; Motala Sweden
• Manufacturer 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.
• FDA Determined 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 in Commerce: 1,484,100 units
• Distribution: Worldwide distribution - US Nationwide distribution and the countries of Sweden, Taiwan, Hong Kong, and Spain.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.