The U.S. FDA has posted several class I recalls in recent days, including a removal of one model of the Medtronic Vascular’s Pipeline Vantage embolization device due to insufficient apposition to the vessel wall.
The U.S. FDA announced a class I recall declared by Baxter Healthcare Corp., of Deerfield, Ill., for the automated compounding inlets used with the company’s Exactomix compounding systems due to the risk of particulate matter in the inlets.
The FDA reported several class I recalls in the first week of September 2024, a list that includes products such as Medtronic plc’s McGrath line of laryngoscopes, some of which should be jettisoned.
A dongle is not the sort of thing one typically associates with a medical device, but a charging dongle used with the Baxter Healthcare Life2000 ventilator has triggered a recall of both the dongle and the ventilator.
The U.S. FDA advises health care providers (HCPs) to avoid using Monoject syringes distributed by Cardinal Health with syringe pumps or patient-controlled analgesia (PCA) pumps because of incompatibilities between the Monoject interface and the pumps.
In a balancing act between supply and drug quality, the U.S. FDA tipped the scales on behalf of quality, slapping an import alert on Intas Pharmaceuticals Ltd. in June, followed by a July 28 warning letter requiring the India-based company to develop and implement a global corrective action and preventive action plan.
In a balancing act between supply and drug quality, the U.S. FDA tipped the scales on behalf of quality, slapping an import alert on Intas Pharmaceuticals Ltd. in June, followed by a July 28 warning letter requiring the India-based company to develop and implement a global corrective action and preventive action plan.
Device recalls pop up with no regard to human appreciation for seasonality, and thus it was that recalls involving three major medical device makers emerged as the steamy month of July gave way to the arid, oppressive swelter of August. These recalls affected more than 7,500 units of the Trusignal pulse oximeter by GE Healthcare Technologies Inc., nearly 23,000 units of the Sigma Spectrum and Spectrum IQ infusion pumps by Baxter Healthcare Corp., and an unspecified number of units of the Carina ventilator by Drägerwerk AG, all of which adds a little more than the usual heat to the device industry’s dog days.
Becton, Dickinson & Co. (BD) recalled intraosseous needle set kits and power drivers. The action was triggered by difficulties in separating the stylet from the needle. The FDA also announced a class I recall of the Volara respiratory clearance system by Baxter Healthcare Corp., of Deerfield, Ill., because of issues with an in-line ventilator adapter.
The FDA applied a class I tag to the recall of Dose IQ software used in infusion pumps made by Baxter Healthcare because of a defect in the software, although there have been no reported injuries or fatalities. The defect is blamed for creating mismatches between the drug library and the drug loaded into the infusion pump, which can lead to potentially deadly over- or under-infusion of the medication.
