Health product recall

Pico50 Arterial Blood Sampler

Last updated

Summary

Product
Pico50 Arterial Blood Sampler
Issue
Medical devices - Sterility Issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Pico50 Arterial Blood Sampler

All lots.

956-552

Issue

Radiometer has been performing integrity testing of the Pico50 arterial blood sampler packaging material. Integrity studies included sterility testing to show that the integrity of the sterile barrier system is intact. In the 24 month real time study, 1 out of 40 samples did not pass the sterility test acceptance criteria. This indicates that the sterile barrier system is compromised after 2 years storage and maintaining the product sterile throughout the shelf life cannot be showed.

Recall start date: Apr 13, 2022

Additional information

Details
Original published date: 2022-04-28
Alert / recall type
Health product recall
Category
Health product - Medical device - Anaesthesiology
Companies

Radiometer Medical Aps

Akandevej 21, Bronshoj

Denmark, 2700

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64108