AB ULAX recalls 1500 Flex Heat and Moisture Exchangers due to risk of disconnection during use, potentially causing lack of oxygen and hypoxia. Affected units have specific catalog references and production dates.
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.
AB ULAX is recalling 1500 Flex Heat and Moisture Exchangers after reports of them disconnecting from ventilator circuits during use. This could lead to inadequate oxygen delivery, causing hypoxia or death in patients.
The Heat Moisture Exchanger (HME) can disconnect from the ventilator circuit while in use. If disconnected, the circuit may not provide sufficient oxygen, leading to hypoxia or death in patients.
Patients using ventilators with AB ULAX 1500 Flex Heat and Moisture Exchangers are at risk. Healthcare providers and critical care facilities using these devices may be affected.
Check for catalog reference 1500 Flex Heat and Moisture Exchangers with specific production dates listed in the recall notice. Affected units have production dates from September 2018 to November 2020.
Immediately stop using the affected 1500 Flex Heat and Moisture Exchanger if it disconnects during use.
AB ULAX received 6 complaints that the Heat Moisture Exchanger disconnected from the ventilator circuit during use, which could lead to lack of oxygen and hypoxia.
The affected models are 1500 Flex Heat and Moisture Exchangers with catalog reference 150 and production dates from September 2018 to November 2020.
Check the product's catalog reference and production date against the list provided in the recall notice, which includes specific dates from September 2018 to November 2020.
We’ve drafted a message you can send AB ULAX to request your refund or repair — edit it as you like.
Subject: Recall Z-0059-2021 — AB ULAX AB ULAX Hello, I own a AB ULAX that is covered by recall Z-0059-2021 from AB ULAX. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
