Highlighted articles include:
Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell: Class I Recall
Silver iodide build-up on the chloride electrode, microbial contamination, general non-ISE hardware, and maintenance in the instruments may cause incorrect electrolyte results...
Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall
AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process...
FDA and HRSA Joint Safety Communication: Weck Hem-o-Lok Ligating Clips Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy
Weck Hem-o-Lok Ligating Clips should NOT be used for the ligation of the renal artery during a laparoscopic living-donor nephrectomy because of serious risks to the donor...
Boston Scientific Devices Stolen: Risk of Infection
Boston Scientific Corporation is alerting the public about a stolen shipment of Endoscopy and Urology/Women’s Health medical devices...
Standardizing Emergency Medical Equipment
Interdisciplinary teams focused on quality and efficiency for the organization are instrumental in identifying holes...
Featured HeartNet Reports of Interest
Your reports of actual adverse events and 'potential for harm' medical device related safety concerns are of special interest to FDA, MedSun and HeartNet...
Home Use Devices: How to Prepare for and Handle Power Outages for Medical Devices that Require Electricity
this booklet provides recommendations about actions you should take with your medical device during a power outage or other emergency situation...
Recall of Infant and Neonatal-Sized FilterLine H Set and VitaLine H Set Sampling Lines
Dislodged plastic strands may be found within the airway adapter which may then become inhaled by the patient...
FDA Approves the First Vaccine to Prevent Meningococcal Disease in Infants and Toddlers
FDA has approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135...
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