FDASeptember 4, 2020device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
ab ulax
UPCs
202006301500
Recall history
No related federal recalls on record for this brand yet.
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