FDA recalls two products for potential of serious harm
The Food and Drug Administration July 21 identified Class I recalls of two products due to the potential for serious injury or death. Integra LifeSciences MicroMyst Applicators were recalled due to incomplete bioburden assessments and sterilization location transfer documentation. The recall involves removing devices from where they are used or sold. Maquet Critical Care AB Servo Ventilator Systems were recalled due to a risk of an inaccurate compliance measurement leading to improper tidal volume delivery in neonatal patients. The recall involves updating instructions for using devices.
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