Editor's Note In a June 5 letter to healthcare providers, the Food and Drug Administration (FDA) says it is aware of US healthcare facilities and providers experiencing supply constraints of nonsterile, single-use pneumatic tourniquet cuffs. The cuffs are used in elective limb surgeries and in emergency and trauma settings. During…
Editor's Note The Food and Drug Administration (FDA), on June 5, identified the recall by Abiomed of specific Impella 5.5 with SmartAssist heart pumps as Class I, the most serious. The recall was initiated because of fluid leaking from the purge sidearm of the pump. If the leak issue is…
Editor's Note The Food and Drug Administration (FDA), on May 25, identified the recall by SD BioSensor, Inc, of certain Pilot COVID-19 At-Home Tests as Class I, the most serious. The recall was initiated because the liquid solution in the test kit may be contaminated with bacteria such as Enterococcus,…
Editor's Note The Food and Drug Administration (FDA), on May 24, identified the recall by Draeger Medical of the Seattle PAP Plus as well as VentStar and other breathing circuit/anesthesia kits as Class I, the most serious. The recall was initiated after finding that glued connections may loosen before or…
Editor's Note The Food and Drug Administration (FDA), on May 22, identified the recall by ICU Medical of replacement batteries for its Plum 360, Plum A+, and Plum A+3 infusions systems as Class I, the most serious. The recall was initiated because a manufacturing defect substantially diminished how long the…
Editor's Note The Food and Drug Administration (FDA), on May 11, finalized its recommendations for assessing blood donor eligibility, which uses individual risk-based questions to reduce the risk of transmitting HIV. The questions will be the same for all donors, regardless of sexual orientation, sex, or gender. The new policy…
Editor's Note Estimates from the Centers for Disease Control and Prevention find the emerging COVID-19 Omicron subvariant XBB.1.16, dubbed Arcturus, is responsible for more than 14% of COVID-19 cases in the US over the past 2 weeks, up from nearly 7% in the prior 2 weeks, according to the May…
Editor's Note In response to questions, on April 21, the Food and Drug Administration (FDA) provided an update to its Safety Communication that enables the use of existing inventory of the O&M Halyard FLUIDSHIELD Surgical N95 Respirator Masks, Orange (Regular), Level 3, (Model 46727). The FDA recommends that, if necessary,…
Editor's Note The Food and Drug Administration (FDA), on April 19, identified the recall by Fresenius Kabi USA of its Ivenix Infusion System as Class I, the most serious. The recall was initiated because of a leak in the system that allows fluid to enter the administration set loading area…
Editor's Note The Food and Drug Administration (FDA), on April 13, updated prescribing information for all opioid pain medications, including requiring all packaging to have updated labeling and safety information. This includes stating that: for both immediate-release (IR) and extended release/long acting (ER/LA) opioid pain medications, the risk of overdose…
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