Health Canada — Medical Devices · Canada · 2022-04-25 · Type II
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Reported risk: 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
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