December 2014 MedSun Newsletter
Recalls and Safety Alerts:
Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall
Recall due to mold contamination of some products…
FDA Infusion Pumps Website – Updated
The FDA has updated its’ infusion pumps website. A federal register notice has also been published titled Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff…
Laparoscopic Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication
FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women…
Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall
Affected parts may prevent the ventilator from using AC power or may fail and prevent the ventilator from switching back to AC power after using battery power…
Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall
Software problem may cause the ventilator to stop working after the air and oxygen gas supply lines are disconnected and then reconnected…
Discussions with Healthcare Providers:
Duodenoscopes Used in Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures: Small Sample Survey Summary
The purpose of this survey is to enhance FDA’s understanding of clinicians' perspectives on these devices…
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