VentStar (N) 180 (2021-01-19)

Starting date:

January 19, 2021

Posting date:

January 26, 2021

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-74859

Last updated: 2021-01-26

• Reason
• Affected products

Affected Products

1. VentStar Anesthesia (N) 180
2. VentStar Basic (N) 180

Reason

During the course of global market surveillance activities, manufacturer become aware of cases in which the Y-piece became detached from the ventilation hose either before or during the ventilation process. Further analyses determined that the Y-pieces, due to a manufacturing error, could in some cases become disconnected at tensile forces below what is specified. Consequently, some of the referenced breathing circuits may potentially show a limited lifetime of the adhesive joint. If the Y-piece becomes detached from the hose during use, a leak will be caused that can hinder ventilation of the patient. If the breathing circuit is used with devices that are listed in the instructions for use as being compatible, any leakage will be detected and the device will give an alarm. There were no reports of any adverse impact on the health of the patients in question.

Affected products