Recall Z-0059-2021 ยท BYD Condenser, Heat And Moisture (Artificial Nose)
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.
| Date | Sep 4, 2020 |
| Status | Terminated |
| 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 c |
| Quantity | 1,484,100 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Sweden, Taiwan, Hong Kong, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.