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Medrad Intego PET Infusion System Source Administration Sets by Bayer: Corrective Action
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Medrad Intego PET Infusion System Source Administration Sets by Bayer: Recall
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Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication
[Posted 01/11/2017] AUDIENCE: Cardiology, Surgery, Emergency Medicine, Radiology ISSUE: The FDA has received reports of serious adverse events, including patient injury and death, associated with the use of implantable infusion pumps in the MR environment. These reports describe medication dosing inaccuracies (e.g., over-infusion or under-infusion, unintended bolus) and other mechanical problems with the pump (e.g.,…
Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication
[Posted 01/09/2017] AUDIENCE: Cardiology, Surgery, Family Practice, Patient ISSUE: The FDA is providing information and recommendations regarding St. Jude Medical’s radio frequency (RF)-enabled implantable cardiac devices and Merlin@home Transmitter to reduce the risk of patient harm due to cybersecurity vulnerabilities. The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical’s Merlin@home…
ZIKV Detect IgM Capture ELISA by InBios International, Inc: FDA Safety Communication
[Posted 12/23/2016] AUDIENCE: OBGYN, Internal Medicine, Infectious Disease, Family Practice ISSUE: The FDA is alerting physicians who care for pregnant women meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, that the U.S. commercial testing facility, Laboratory Corporation of America (LabCorp), has reported some false positive results from the ZIKV Detect test….
Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall
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Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication
[Posted 12/16/2016] AUDIENCE: Internal Medicine, Pharmacy, Psychiatry ISSUE: Based on an FDA review of a large clinical trial that FDA required the drug companies to conduct, FDA determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. The risk…
General Anesthetic and Sedation Drugs: Drug Safety Communication
[Posted 12/14/2016] AUDIENCE: Consumer, Surgery, Anesthesiology ISSUE: FDA is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains. Consistent with animal studies, recent human studies suggest that…
Pioglitazone-containing Medicines: Drug Safety Communication
Includes Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni [Posted 12/12/2016] AUDIENCE: Internal Medicine, Endocrinology, Urology ISSUE: As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder…