BAYLIS V4C-560 VENTILATOR (2021-07-05)

Starting date:

July 5, 2021

Posting date:

July 22, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-76071

Last updated:
2021-07-22

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  Reason
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  Affected products

Affected Products 

BAYLIS V4C-560 VENTILATOR

Reason

Baylis Medical Company Inc. is voluntarily recalling 2 units of the Baylis Medical V4C‐560 Ventilator to investigate and if applicable, correct a labeling error on the Ventilator keypad. The affected 2  Baylis Medical V4C‐560 Ventilator units have covidien branding and incorrect device identification on the keypad. Baylis needs to recall these 2 units to investigate the source of the labeling error. As a result of the manner in which these units have been handled by third parties, the safety of these 2 units cannot be assured before completing this investigation.

Affected products