Highlighted articles include:
HiRes 90K Cochlear Implant Device: Recall – Malfunction
Advanced Bionics is recalling its HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution...
Micromedics, Inc. Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes - Class 1 Recall
Sterile pouches of affected products may have weak or open seals...
Needleless Pre-filled Glass Syringes - Stakeholder Advisory
Reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless IV access systems...
Sigma Spectrum Infusion Pump Model 35700 - Class 1 Recall
Affected units may fail suddenly, causing inaccurate flow conditions during use...
Triton Pole Mount Infusion Pump by WalkMed - Class 1 Recall
If the pump door is not closed and latched per the instructions for use, the door open alarm may not alert the user...
Hospira Symbiq One-Channel and Two-Channel Infusers - Class I Recall
Motor encoder failures in the pumping mechanism may cause the infuser to cease operation...
Reduce and Report Enteral Feeding Tube Misconnections
All adverse events and “near misses” should be reported to the FDA, whether they’re considered device or human error...
Safety Investigation of CT Brain Perfusion Scans - Update
FDA is working with manufacturers of CT scanners to improve instructions and training programs...
10 Point Yearly Safety Checklist
Lab safety checklists are a work in progress, but a committment should be made to update and account for new hazards...
Proper Eye Protection
Tips on preventing eye injuries...
Thioglycollate Culture Media and Tissue Samples - MedSun Small Sample Survey Summary
Lab professionals' experiences with the use of thioglycollate media with gram stain procedures...
External Defibrillator Improvement Initiative
FDA initiative to foster the development of safer and more effective external defibrillators through improved design and manufacturing practices...
Home Hemodialysis Systems: MedSun Small Sample Survey Summary
Users' experiences with home hemodialysis (HHD) systems...
Adverse Events Associated with Neonatal Laparoscopy: Are They Truly Rare Events or the Tip of the Iceberg?
Recent reports of catastrophic events associated with neonatal laparoscopy may suggest that its popularity is unfounded for minor procedures...
Webcast: PICC and Umbilical Catheter Safety in Neonatal Patients
Medical device safety during insertion and care of peripherally inserted central catheters (PICC) and umbilical catheters in neonatal patients...
You are subscribed to the MedSun Website, part of U.S. Food & Drug Administration (FDA).
The content on the Homepage has been updated to reflect this month's Newsletter items. This information can be viewed by clicking here.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Manage your FDA Subscriptions:
- Update your preferences or unsubscribe
- Questions about this service? support@xxxxxxxxxxxxxxx
- Other inquiries? webmail@xxxxxxxxxx
U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420
