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Pico50 arterial blood sampler
Official notice
25 Apr 2022
Last checked
25 Apr 2022
An official Health Canada notice concerns Pico50 arterial blood sampler. 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 Published 2022-04-25.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64108
Official notice
2022-04-25
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Radiometer Medical Aps, Pico50 Arterial Blood Sampler.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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