[Posted 08/21/2015] AUDIENCE: Dermatology, Pharmacy, Patient ISSUE: FDA is warning about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate). FDA received reports of cases involving severe eye injuries and skin reactions associated with the application of Picato gel. Some cases were associated with Picato gel…
OxyTOTE Portable Oxygen Unit by Western/Scott Fetzer Company: Class I Recall
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Prolotherapy with Phenol by Hartley Medical: Recall – Non
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Compounded or Repackaged Drugs Stored in Becton-Dickinson (BD) 3 mL and 5 mL Syringes: FDA Alert
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Compounded Drugs Stored in Becton-Dickinson (BD) 3 ml and 5 ml Syringes: FDA Warning
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Mammograms at Boston Diagnostic Imaging in Orlanda, Florida: FDA Safety Communication
[Posted 08/17/2015] AUDIENCE: Family Practice, OBGYN, Oncology, Radiology, Patient ISSUE: FDA is alerting patients who had mammograms at Boston Diagnostic Imaging located in Orlando, Florida, anytime on or after May 13, 2013, about possible problems with the quality of their mammograms. The American College of Radiology (ACR) conducted a clinical image review of mammograms performed…
Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall
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Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication
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Gilenya (fingolimod): Drug Safety Communication
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Duodenoscope Reprocessing: FDA Safety Communication
Includes all Endoscopic Retrograde Cholangiopancreatography (ERCP) endoscopes (side-viewing duodenoscopes) [Posted 08/04/2015] AUDIENCE: Gastroenterology, Surgery, Biomedical Engineering, Infectious Disease, Nursing, Risk Manager ISSUE: FDA is providing a detailed list of supplemental duodenoscope reprocessing measures that emerged from an agency-led expert panel meeting earlier this year. Hospitals and health care facilities that utilize duodenoscopes can, in addition…