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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 2025185
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 2025229
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 2025297
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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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 2025181
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 2025179
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

 
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Oxygen Concentrator Recall: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD Removes JMC5A Ni/TruAire-5 Oxygen Concentrator due to the devices spontaneously catching fire

Murilo Freitas - 05:00, 4 de February de 2025231
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD is recalling certain devices due to incidents of device melting and fire during the use of oxygen concentrators.

http://www.fda.gov/medical-devices/medical-device-recalls/oxygen-concentrator-recall-jiangsu-jumao-x-care-medical-equipment-co-ltd-removes-jmc5a-nitruaire-5

 
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Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks

Murilo Freitas - 05:00, 2 de February de 2025286
Becker and Exacta EDMS are used for draining and monitoring cerebrospinal fluid in the brain. Stopcocks may have cracks or leaks that pose a risk to patients.

http://www.fda.gov/medical-devices/medical-device-recalls/pressure-monitoring-device-recall-medtronic-neurosurgery-issues-correction-becker-and-exacta

 
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