Anesthesiologists
FDA: Class I recall of Hamilton-C6 Intensive Care Ventilator
Editor's Note The Food and Drug Administration (FDA) on August 29 identified the recall by Hamilton Medical AG of its Hamilton-C6 Intensive Care Ventilator as Class I, the most serious. The recall was initiated because of potential water ingress between the indicator board and the ventilator’s main board that may…
FDA: Hospira recalls another lot of Propofol
Editor's Note The Food and Drug Administration (FDA) on August 22 posted the Hospira Inc (a Pfizer company) recall of one lot of Propofol Injectable Emulsion (containing Benzyl alcohol), 100 mL single patient use glass fliptop vials, lot EA7470. The recall was initiated because of visible particulates observed in two…
ISMP publishes new perioperative medication safety guidelines
Editor's Note The Institute for Safe Medication Practices (ISMP) on August 11 announced the publication of its first set of safe practice guidelines to support perioperative medication safety in hospitals, ambulatory surgery centers, and other procedural locations. The new guidelines: Address best practices related to labeling and storage of perioperative…
FDA: Class I recall of BD Intraosseous Infusion System
Editor's Note The Food and Drug Administration (FDA) on August 11 classified the recall by Becton Dickinson (BD) of its Intraosseous Infusion System, which includes Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers, as Class I, the most serious. The recall was initiated for three separate…
FDA: Hospira recalls one lot of Propofol
Editor's Note The Food and Drug Administration (FDA), on July 13, posted a nationwide recall by Hospira Inc (a Pfizer Company) of one lot (DX9067) of Propofol Injectable Emulsion, USP (containing Benzyl alcohol), 100 mL single patient use glass fliptop vial. The recall was initiated because of visible particulate observed…
FDA: Class I recall of certain Smiths Medical Medfusion Syringe Infusion Pumps
Editor's Note The Food and Drug Administration on July 20 identified the recall by Smiths Medical of certain Medfusion 3500 and 4000 Syringe Infusion Pumps as Class I, the most serious. The recall was initiated because of eight software malfunctions that affect different serial numbers and software versions. There have…
FDA: Class I recall of Getinge Flow-c, Flow-e Anesthesia Systems
Editor's Note The Food and Drug Administration (FDA) on July 6 identified the recall by Getinge USA Sales Inc of its Flow-c and Flow-e Anesthesia Systems as Class I, the most serious. The recall was initiated after reports of cracked or broken on/off switchs on the systems’ suction units. If…
FDA: Class I recall of GE Healthcare’s CARESCAPE R860 Ventilator
Editor's Note The Food and Drug Administration (FDA) on June 28 identified the recall by GE Healthcare of its CARESCAPE R860 Ventilator as Class I, the most serious. The recall was initiated because the ventilator backup batteries, including replacement backup batteries, may run out before they are expected to do…
FDA: Class I recall of Baxter’s Volara system with in-line ventilator adaptor
Editor's Note The Food and Drug Administration (FDA) on June 23 identified the recall by Baxter Healthcare Corporation of its Volara system with in-line ventilator adaptor as Class I, the most serious. The Volara system is used to clear mucus out of airways, expand lungs, and treat or prevent pulmonary…
FDA: Class I recall of one lot of Draeger SafeStar 55 Breathing System Filters
Editor's Note The Food and Drug Administration (FDA) on June 21 identified the recall by Draeger, Inc, of one lot (LT2103) of its SafeStar 55 Breathing System Filters as Class I, the most serious. The Breathing System Filter is used as part of a ventilator when a patient is under…
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