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.
Related News Articles
Headline
The Food and Drug Administration has identified a Class I recall of certain convenience kits by AVID Medical that contain recalled Medline Namic Angiographic…
Headline
The Food and Drug Administration has issued early alerts for the following products: • Certain epidural kits by Medical Action…
Headline
The Food and Drug Administration has identified a Class I recall of certain Medline convenience kits containing B. Braun components that have Huons Bupivacaine…
Headline
The Food and Drug Administration Aug. 3 identified Class I recalls of two convenience kit products. Certain kits by Medline…
Headline
The Food and Drug Administration has identified Class I recalls of two products: certain Astral ventilators by Resmed due to a supercapacitor that may leak…
Headline
Baxter is voluntarily recalling a specific lot of intravenous solution due to a report of particulate matter in the solution identified as cardboard, according…