1500 Flex Heat Moisture Exchanger (2020-09-11)

Starting date:

September 11, 2020

Posting date:

October 6, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74075

Last updated:
2020-10-06

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  Reason
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  Affected products

Affected Products

1500 Flex Heat Moisture Exchanger

Reason

This recall was initiated following reports that the Heat Moisture Exchanger disconnected from the closed respiratory circuit during use. If the HME device were to disconnect while in the ventilator circuit, the ventilator circuit may not provide adequate ventilation to the patient which could potentially result in injury due to lack of oxygen, including brain damage and death.

Affected products