PNEUMOSTAT CHEST DRAIN VALVE (2021-09-01)

Starting date:

September 1, 2021

Posting date:

September 24, 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-76497

Last updated:
2021-09-24

• 
  Reason
• 
  Affected products

Affected Products

PNEUMOSTAT CHEST DRAIN VALVE

Reason

Atrium/Getinge is initiating a voluntary medical device correction for the Atrium Pneumostat chest drain valve due to the instructions for use (IFU) not providing sufficient precautions/warnings/contraindications related to use of a Pneumostat chest drain value in a ventilated, Preterm infant, requiring treatment for Bilateral Tension Pneumothorax, that resulted in unreasonable patient risk and harm, and subsequent death.

Affected products