|
May MedSun Newsletter
Recalls and Safety Alerts:
StrataMR Adjustable Valves and Shunts by Medtronic: Recall
Voluntary recall due to an issue that can occur post-implantation that can lead to the potential for under-drainage of cerebrospinal fluid.
Newport HT70 and HT70 Plus Ventilators by Medtronic: Field Corrective Action
The voluntary field corrective action is being conducted following reports that the ventilator may reset spontaneously during normal operation, without an accompanying alarm. Following the reset, the ventilator enters standby mode and will not resume ventilation without intervention.
EpiPen and and EpiPen Jr Auto-Injector: Recall
The manufacturer has expanded a voluntary recall of select lots of these devices due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency.
Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall
Recall due to a defect which may cause the tip to separate from the sheath during the insertion procedure, if this occurs, the tip could enter the patient's bloodstream.
HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall
Recall due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy. The device may also unexpectedly stop pacing.
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332) |
 |
| 
