Current Newsletter: September 2015 (PDF - 487KB)
Articles available within the current newsletter:
- In Brief - Recalls and Safety Alerts
- Highlighted Reports
- Links to FDA/CDRH Databases and Other Information Sources
Recalls and Safety Alerts:
Alaris Syringe Pump by CareFusion: Class I Recall
An error in the Alaris Syringe Pump model number 8110 triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the patient…
An error in the Alaris Syringe Pump model number 8110 triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the patient…
Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall
The use of this part can result in over or under infusion of fluids to the patient…
The use of this part can result in over or under infusion of fluids to the patient…
Hudson RCI Sheridan Sher-I-Bronch Endobroncial Tube by Teleflex Medical: Class I Recall
The endobroncial tube’s double swivel connector may break or separate on the tube…
The endobroncial tube’s double swivel connector may break or separate on the tube…
OxyTOTE Portable Oxygen Unit by Western/Scott Fetzer Company: Class I Recall
The company received reports that when the OxyTote is mishandled or dropped, the oxygen cylinder may ignite causing an internal flash fire and the canister to burst…
The company received reports that when the OxyTote is mishandled or dropped, the oxygen cylinder may ignite causing an internal flash fire and the canister to burst…
Mammograms at Boston Diagnostic Imaging in Orlanda, Florida: FDA Safety Communication
FDA is alerting patients who had mammograms at Boston Diagnostic Imaging located in Orlando, Florida, anytime on or after May 13, 2013, about possible problems with the quality of their mammograms…
FDA is alerting patients who had mammograms at Boston Diagnostic Imaging located in Orlando, Florida, anytime on or after May 13, 2013, about possible problems with the quality of their mammograms…
Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication
FDA is alerting health care providers, patients, and caregivers about serious adverse events associated with LVADs. These adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with Thoratec’s HeartMate II and a high rate of stroke with the HeartWare HVAD since approval of the devices…
FDA is alerting health care providers, patients, and caregivers about serious adverse events associated with LVADs. These adverse events include an increased rate of pump thrombosis (blood clots inside the pump) with Thoratec’s HeartMate II and a high rate of stroke with the HeartWare HVAD since approval of the devices…
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