OXYLOG 3000 SYSTEM - DISPOSABLE VENTILATION HOSE (2016-06-02)

Starting date:

June 2, 2016

Posting date:

June 16, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-58926

• Reason
• Affected products

Affected products

1. OXYLOG 3000 SYSTEM - DISPOSABLE VENTILATION HOSE

Reason

During the course of routine internal testing, the firm detected isolated episodes of leakage at the check valve (one way valve of the inspiration branch) of the disposable pediatric ventilation hose of Oxylog 3000 system and Oxylog plus, model 5704964. Affected circuits with this fault were potentially distributed to customers. All other ventilation circuits for the Oxylog family of devices are not affected.

Leakage at the check valve can result in patient's exhaled gas entering into the breathing circuit, which could lead to the rebreathing of the same exhaled gas with reduced oxygen concentration/elevated CO₂ for the patient. This leakage is not detected during the ventilator operational readiness check.

Affected products