Category Archives: Anesthesiology

Spacelabs Anesthesia Workstations and Service Kits Class I Recall

Share

Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits: Class I Recall – Bag-to-Vent Switch in CAS I/II Absorbers May Fail AUDIENCE: Risk Manager, Anesthesiology ISSUE: FDA notified healthcare professionals of a Class I Recall due to a potential defect in … Continue reading

Share
Posted in Anesthesiology, FDA 2013, FDA Recall, Risk Manager | Tagged , , , , , , , , , , , , , , , | Comments Off on Spacelabs Anesthesia Workstations and Service Kits Class I Recall

Low Molecular Weight Heparins Drug Safety Communication

Share

Low Molecular Weight Heparins: Drug Safety Communication – Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis AUDIENCE: Pharmacy, Cardiology, Anesthesiology ISSUE: The U.S. Food and Drug Administration (FDA) is recommending that health care professionals carefully consider the timing … Continue reading

Share
Posted in Anesthesiology, Cardiology, FDA 2013, FDA Safety Communication, Pharmacy | Tagged , , , , , , , , , | Comments Off on Low Molecular Weight Heparins Drug Safety Communication

Engström Ventilator Aespire View Aisys And Avance Anesthesia Machines

Share

Engström Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action – Potential Safety Issue AUDIENCE: Risk Manager, Anesthesiology, Health Professional ISSUE: GE Healthcare has initiated a voluntary field corrective action due to a potential safety issue that … Continue reading

Share
Posted in Anesthesiology, FDA 2013, FDA Recall, Healthcare Professionals, Risk Manager | Tagged , , , , , , , , , , , , , , | Comments Off on Engström Ventilator Aespire View Aisys And Avance Anesthesia Machines

Avance Aisys And Avance CS2 Anesthesia Delivery Systems

Share

Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action – Potential Safety Issue AUDIENCE: Risk Manager, Anesthesiology, Health Professional ISSUE: GE Healthcare has initiated a voluntary field corrective  for the Avance, Aisys and Avance CS2 anesthesia delivery systems … Continue reading

Share
Posted in Anesthesiology, FDA 2013, FDA Notice, Healthcare Professionals, Risk Manager | Tagged , , , , , , , , , , , , , | Comments Off on Avance Aisys And Avance CS2 Anesthesia Delivery Systems

Fabius Anesthesia Machines Recall

Share

Fabius Anesthesia Machines: Recall – Did Not Pass High Voltage Test Portion Of Final Production Test AUDIENCE: Risk Manager, Anesthesiology, Critical Care Medicine ISSUE: Dräger issued a statement regarding its voluntary recall on specific Fabius anesthesia machines. Investigations determined that on … Continue reading

Share
Posted in Anesthesiology, Critical Care Medicine, FDA 2013, FDA Recall, Risk Manager | Tagged , , , , , , , , | Comments Off on Fabius Anesthesia Machines Recall

Carefusion Avea Ventilator Recall

Share

Carefusion Avea Ventilator: Recall – Underreporting Of Tidal Volume If used In Conjunction With Neonatal Hotwire Flow Sensor AUDIENCE: Risk Manager, Anesthesiology, Critical Care Medicine ISSUE: CareFusion announced a voluntary recall of AVEA ventilators regarding barometric pressure sensor compensation when … Continue reading

Share
Posted in Anesthesiology, Critical Care Medicine, FDA 2013, FDA Recall, Risk Manager | Tagged , , , , , , , , , | Comments Off on Carefusion Avea Ventilator Recall

Bupivacaine HCL Injection by Hospira Recall

Share

Bupivacaine HCL Injection 0.25% (2.5 MG/ML) and Bupivacaine HCL 0.75% (7.5 MG/ML), 30 ML Single-Dose Vials by Hospira, Inc.: Recall- Presence of Particulate Matter AUDIENCE: Pharmacy, Anesthesia, Surgery ISSUE: Hospira, Inc. on July 12, 2013, initiated a voluntary nationwide recall … Continue reading

Share
Posted in Anesthesiology, FDA 2013, FDA Recall, Pharmacy, Surgery | Tagged , , , , , , , , | Comments Off on Bupivacaine HCL Injection by Hospira Recall

Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube Class 1 Recall

Share

Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: Class 1 Recall – Mislabeled Packaging AUDIENCE: Anesthesiology, Emergency Medicine, Nursing, Pediatrics, Risk Manager ISSUE: The outside of the device packaging stated a 3.0mm neonatal tube. The product inside the box was actually … Continue reading

Share
Posted in Anesthesiology, Emergency Rooms, FDA 2013, FDA Recall, Nursing, Pediatrics, Risk Manager | Tagged , , , , , , , , , , , , , , | Comments Off on Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube Class 1 Recall

Respironics California Inc Class 1 Recall V60 Ventilators

Share

Respironics California, Inc. – Class 1 Recall: V60 Ventilators – Issue with software AUDIENCE: Risk Manager, Anesthesiologist, Surgeon ISSUE: Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 … Continue reading

Share
Posted in Anesthesiology, FDA 2013, FDA Recall, Risk Manager, Surgery | Tagged , , , , , , , , , , | Comments Off on Respironics California Inc Class 1 Recall V60 Ventilators

Symbios GOPump GOBlock Kits Class 1 Recall

Share

Symbios GOPump and GOBlock Kits: Class 1 Recall – Potential for Excessive High Flow Rates [06/12/2013] AUDIENCE: Surgery, Anesthesia, Risk Managers ISSUE: FDA and Symbios are informing the public of a recall  of all GoPump Rapid Recovery System kits and … Continue reading

Share
Posted in Anesthesiology, FDA 2013, FDA Recall, Risk Manager, Surgery | Tagged , , , , , , , , , , , , | Comments Off on Symbios GOPump GOBlock Kits Class 1 Recall