Recalls:
Respironics, Inc. Trilogy 100 Ventilators: Class I Recall
Device may stop delivering therapy to a patient...
Ikaria INOmax DS Drug Delivery System: Class I Recall
Erratic nitric oxide (NO) monitoring readings were being caused by fretting corrosion at the electrical contact interface of certain metals...
Safety Alerts:
CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure (Update)
FDA is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82 by the manufacturer...
Urogynecologic Surgical Mesh Implants - (Update)
FDA is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III...
FDA Targets Risks From Reused Medical Devices
Some medical devices are reused many times in common surgical and diagnostic procedures, FDA wants to ensure they are safely reused...
Workshops:
Using Scientific Research Data to Support Pediatric Medical Device Claims: A Public Dialogue - (Update)
The workshop transcript is now available...
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