Tag: FDA

ASA suggests patients stop popular weight loss medications before elective surgery

Editor's Note The American Society of Anesthesiologists (ASA) announced on June 29 that patients taking any of the currently popular medications for weight loss or for the treatment of type 2 diabetes should withhold the medication prior to elective surgery to "reduce the risk of complications associated with anesthesia in…

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By: Tarsilla Moura
July 5, 2023
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FDA: Class I recall of Arrow Endurance Extended Dwell Peripheral Catheter System

Editor's Note The Food and Drug Administration (FDA), on June 26, identified the recall by Teleflex, and their subsidiary Arrow International, of the Arrow Endurance Extended Dwell Peripheral Catheter System as Class I, the most serious. The recall was initiated because of the risk of catheter separation and leakage. If…

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By: Judy Mathias
June 27, 2023
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Pfizer warns FDA of penicillin shortage

Editor's Note Pfizer alerted the Food and Drug Administration (FDA) on June 12 that its supply of two forms of injectable penicillin—Bicillin L-A and Bicillin C-R—may run out by the end of this month, the June 13 The Hill reports. Pfizer cited a combination of factors for the shortage, including…

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By: Judy Mathias
June 15, 2023
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FDA: Class I recall of Walnut Wearable Smart Thermometers

Editor's Note The Food and Drug Administration, on June 12, identified the recall of the rechargeable Walnut Wearable Smart Thermometer as Class I, the most serious. BearCare, Inc, is recalling the thermometers after receiving reports of skin burns and irritation resulting from use of the device. The company reports five…

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By: Judy Mathias
June 14, 2023
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FDA letter on supply shortage of nonsterile, single-use pneumatic tourniquet cuffs

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…

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By: Judy Mathias
June 12, 2023
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FDA: Class I recall of specific Abiomed Impella 5.5 with SmartAssist heart pumps

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…

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By: Judy Mathias
June 5, 2023
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FDA: Class I recall of certain SD BioSensor Pilot COVID-19 At-Home Tests

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,…

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By: Judy Mathias
May 30, 2023
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FDA: Class I recall of Draeger Medical’s Seattle PAP Plus, breathing circuit/anesthesia kits

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…

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By: Judy Mathias
May 26, 2023
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FDA: Class I recall of certain ICU Medical infusion system batteries

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…

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By: Judy Mathias
May 23, 2023
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FDA finalizes recommendations for blood donations

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…

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By: Judy Mathias
May 22, 2023
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