Murilo Freitas – Page 7

BD Announces Voluntary Worldwide Recall for One Lot of ChloraPrep™ Clear 1 mL Applicators Due to Fungal Contamination

Murilo Freitas - 05:00, 17 de February de 2025130

BD (Becton, Dickinson and Company) today announced the voluntary recall of one lot of ChloraPrep™ Clear 1 mL Applicators due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-announces-voluntary-worldwide-recall-one-lot-chlorapreptm-clear-1-ml-applicators-due-fungal

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FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes

Murilo Freitas - 19:59, 13 de February de 2025121

FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
http://www.fda.gov/news-events/press-announcements/fda-approves-first-rapid-acting-insulin-biosimilar-product-treatment-diabetes

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Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal

Murilo Freitas - 05:00, 13 de February de 2025133

Heart Pump Recall: Abiomed, Inc. Updates Use Instructions for Impella RP with SmartAssist and Impella RP Flex with SmartAssist Due to A Risk That the Tip of Guidewires or Other Medical Devices May Come into Contact with The Impella Pump During Insertion, Adjustment, Or Removal

http://www.fda.gov/medical-devices/medical-device-recalls/heart-pump-recall-abiomed-inc-updates-use-instructions-impella-rp-smartassist-and-impella-rp-flex

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ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling

Murilo Freitas - 05:00, 13 de February de 2025126

ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Inj. 20 mEq, to the user level. ICU medical has received a customer complaint which states that bags of POTASSIUM CHLORIDE Inj. 20 mEq have inco

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/icu-medical-issues-nationwide-recall-potassium-chloride-injection-20-meq-and-potassium-chloride

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Breathing Circuit Kit Recall: Sentec/Percussionaire Removes VDR4 Phasitron Breathing Circuits due to Venturi Component Malfunctions that May Reduce Pressure and Volume Flow

Murilo Freitas - 05:00, 9 de February de 2025141

Phasitron Breathing Circuits support continuous ventilation. A malfunctioning venturi component in the circuit may cause reduced oxygen flow.

http://www.fda.gov/medical-devices/medical-device-recalls/breathing-circuit-kit-recall-sentecpercussionaire-removes-vdr4-phasitron-breathing-circuits-due

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Arterial Catheter Recall: Medline Industries, LP, Removes Integrated Arterial Catheters due to Excess Material at Catheter Hub that May Detach

Murilo Freitas - 05:00, 5 de February de 2025176

Medline Integrated Arterial Catheters continuously monitor blood pressure. Excess material on the catheter hub that may detach and enter the patient.

http://www.fda.gov/medical-devices/medical-device-recalls/arterial-catheter-recall-medline-industries-lp-removes-integrated-arterial-catheters-due-excess

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Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular

Murilo Freitas - 05:00, 5 de February de 2025117

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-atherectomy-catheter-system-issue-bard-peripheral-vascular

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FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices

Murilo Freitas - 16:35, 4 de February de 2025140

FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices
http://www.fda.gov/news-events/press-announcements/fda-alerts-patients-potential-miss-critical-safety-alerts-due-phone-settings-when-using-smartphone

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Continuous Ventilator Correction: Baxter Healthcare Corporation Issues Correction for Life2000 Ventilator due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable

Murilo Freitas - 05:00, 4 de February de 2025110

Baxter Healthcare is recalling the Life2000 Ventilator System by correction, due to a defective battery charger making the ventilator inoperable.

http://www.fda.gov/medical-devices/medical-device-recalls/continuous-ventilator-correction-baxter-healthcare-corporation-issues-correction-life2000-ventilator

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FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes

Murilo Freitas - 05:00, 4 de February de 2025113

The FDA is alerting users of diabetes-related medical devices that smartphones connected to diabetes devices may fail to send critical safety alerts.

http://www.fda.gov/medical-devices/safety-communications/fda-alerts-patients-regularly-check-diabetes-related-smartphone-device-alert-settings-especially