A. AMSORB PLUS PREFILLED G-CAN W TO V (2021-08-04)

Starting date:

August 4, 2021

Posting date:

August 19, 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-76267

Last updated:
2021-08-19

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  Reason
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  Affected products

Affected Products 

1. AMSORB PLUS PREFILLED G-CAN W TO V
2. AMSORB PLUS G-CAN

Reason

Armstrong Medical is aware of reports indicating that a small number of devices are associated with high and unexpected resistance to gas flow during clinical use. Such resistance could impact or prevent adequate ventilation of an anesthetized patient, should a defective device go into clinical use. Assessment of available data and results from product testing suggest that these devices account for 0.25% of devices manufactured from June 2020 until 11th June 2021.

Affected products