FDA: Class I recall of Medtronic Xomed NIM Contact, NIM Standard Reinforced EMG Endotracheal Tubes
Editor's Note The Food and Drug Administration on September 12 identified the recall by Medtronic Xomed of its NIM Contact Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube as Class I, the most serious. The recall was initiated after Medtronic Xomed received customer complaints about obstruction of…
FDA: Reports of squamous cell carcinomas, lymphomas in breast implant scar tissue
Editor's Note The Food and Drug Administration (FDA) on September 8 issued a Safety Communication informing the public about reports of cancers, including squamous cell carcinomas and various lymphomas in the scar tissue that forms around breast implants. The various lymphomas are not the same as the lymphomas reported in…
FDA alerts patients, providers of Philips Respironics masks recall
Editor's Note The Food and Drug Administration (FDA) issued a safety communication alert on September 6 informing patients, caregivers, and healthcare providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due…
FDA: Class I recall of Integra’s CereLink ICP Monitor
Editor's Note The Food and Drug Administration (FDA) on August 31 identified the recall by Integra of its CereLink ICP Monitor as Class I, the most serious. The recall was initiated because the device may display incorrect values for a patient’s intracranial pressure (ICP) and display out-of-range pressure readings. If…
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: Class I recall of Intera 3000 Hepatic Artery Infusion Pump
Editor's Note The Food and Drug Administration on August 29 identified the recall by Intera Oncology of its Intera 3000 Hepatic Artery Infusion Pump as Class I, the most serious. The company is recalling the pumps after receiving reports from clinicians that the pumps were delivering medication faster than expected.…
FDA: Class I recall of Medtronic’s HeartWare HVAD system batteries
Editor's Note The Food and Drug Administration on August 25 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system batteries as Class I, the most serious. Medtronic is recalling the batteries because they may experience electrical faults that cause them to unexpectedly fail. A similar recall…
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…
FDA: Class I recall of Medtronic Cobalt/Crome ICDs, CRT-Ds
Editor's Note The Food and Drug Administration (FDA) on August 19 identified the recall by Medtronic of its Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) as Class I, the most serious. The devices are being recalled because of reports of short circuit-protection…
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…
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