Health Canada — Medical Devices · Canada · 2020-06-12 · Type II
As described by Health Canada — Medical Devices: CLINITUBES with Capillary Caps & Safe CLINITUBES Blood Sampler (2020-03-03)
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Reported risk: Radiometer Medical ApS has received an increased number of complaints stating that several customers have had troubles when using SafeClinitubes (942-892). The SafeClinitubes have little or no aspiration, which means that it is difficult or impossible to collect the patient blood with the SafeClinitubes. The lack of aspiration may lead to the hazardous situation of delayed availability of fetal scalp pH measurement results during the delivery process.
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