Health product recall

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

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

PNEUMOSTAT CHEST DRAIN VALVE

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

16100

Companies
Manufacturer

ATRIUM MEDICAL CORPORATION

40 CONTINENTAL BLVD

MERRIMACK

New Hampshire

UNITED STATES