Highlighted articles include:
Air or Electric Dermatome Instruments: Medical Device Safety Tip
FDA has received several reports of patients injuries with these devices, in each case the device was out of specification or damaged because of inadequate maintenance...
Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays – Recall
Affected 6PERC or 8PERC Shiley Tracheostomy Tube cuffs may not be able to hold air due to a leak in the pilot balloon inflation assembly...
Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser – Class I Recall
Potential for the device to fail to detect air in line at the end of an infusion...
Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism
Reports of adverse events appear to be related to use of spray devices that is inconsistent with the approved product labeling and instructions for use...
LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc. - Class I Recall
A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and no AC (line) power is available...
Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System - Class I Recall
The firm received increasing numbers of complaints for false negative MRSA results when compared to MRSA positive results received from culture methods...
Microtome Safety
The provided safety tips can help prevent exposure to solvents and biologicals...
Bilirubin: The Lab's Role in Diagnosis of Neonatal Hyperbilirubinemia
More studies on the correlation between transcutaneous devices and clinical laboratory analyzers need to be completed to determine the acceptability of the transcutaneous measurement within the context of screening for hyperbilirubinemia...
Cardiac CT
Standard invasive coronary angiography remains the gold standard for evaluation of coronary anatomy...
Featured HomeNet Report of Interest
Your reports of adverse events, 'potential for harm', 'near miss', and 'close call' medical device-related safety concerns...
FDA Website Provides Information about Pediatric Medical Devices
FDA maintains a pediatric medical device webpage with information on issues associated with medical device use in children...
CONSTELLATION Vision System - Recall
Software and hardware problems have been associated with unexpected system loss of power, unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems...
The Sun & Your Eyes: What You Need to Know
Information on how to reduce the risk of sun damage to the eyes...
Global Perceptions & Vision Care Realities
The diversity of perceptions and beliefs around the world presents significant challenges for vision care companies that operate globally...
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