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Medline Integrated Arterial Catheters continuously monitor blood pressure. Excess material on the catheter hub that may detach and enter the patient.
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Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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FDA Alerts Patients of Potential to Miss Critical Safety Alerts Due to Phone Settings When Using Smartphone-Compatible Diabetes Devices
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
Baxter Healthcare is recalling the Life2000 Ventilator System by correction, due to a defective battery charger making the ventilator inoperable.
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FDA Alerts Patients to Regularly Check Diabetes-Related Smartphone Device Alert Settings, Especially Following Phone Hardware or Software Changes
The FDA is alerting users of diabetes-related medical devices that smartphones connected to diabetes devices may fail to send critical safety alerts.
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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
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.
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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
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.
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Update on Alert: Extracorporeal Blood Circuit Issue from Nuwellis
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Update on Alert: Fluid Delivery Set Issue from Medline
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program