Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient TherapyĪbbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems for Risk of Extreme Heat and Fire ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Deliveryįresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment Recalls Certain Pilot COVID-19 At-Home Tests for Potential Bacteria Contaminationĭraeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support Recalls Rechargeable Walnut Wearable Smart Thermometers for Risks of Serious Injury, including Burns During UseĪbiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support Teleflex and Arrow International Recall ARROW Endurance Extended Dwell Peripheral Catheter System for Risk of Catheter Separation or LeakageīearCare, Inc. Megadyne Recalls MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes for Risk of Serious Burn Injuries to Patients Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonatesĭraeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and Ventilator Stop Recalls Quidel Triage Cardiac Panels for Risk of False Negative Troponin Results that Could Cause Delayed Diagnosis or Missed Myocardial Infarction Medtronic Recalls Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough for Risk of Low or No Energy Output During High Voltage Therapy GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give Inaccurate ReadingsĪbiomed Recalls All Impella Left Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter Aortic Valve Replacement (TAVR) StentĪbbott Recalls Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism ![]() Philips Respironics Recalls Trilogy Evo, Evo O2, EV300, and Evo Universal Ventilators After Finding Dust and Dirt in Air Path That Can Reduce Air Flow to Patientsĭatascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Unexpected Shutdownsīaxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps with Master Drug Library and Spectrum IQ Infusion Systems with Dose IQ Safety Software for Repeat Upstream Occlusion False Alarms Recalls HAMILTON-C1, C2, C3, T1 Ventilators for Software Issues that May Cause Ventilators to Stop Without Noticeĭraeger Recalls Carina Sub-Acute Care Ventilators for Contaminants in AirpathĪbiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clotsĭatascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for PCBA Failures Affecting the Ability to Charge the Batteries Leading to Unexpected Shutdowns Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Power Failures When Device is Unseated from Cart Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Gas Loss and Gas Gain Failures Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Autofill Failure Alarms Resulting in Pump Stops Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for System Over Temperature Alarms Causing Pump Stops ![]() Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-SterileĪbbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) Mode Recalls HAMILTON-C1, T1, MR-1 Ventilators for Capacitator Leaks and Short Circuits Philips Respironics Recalls V60 and V60 Plus Ventilators due to Power Management Printed Circuit Board Assemblies (PM PCBAs) Not Meeting Ventilator Standards Olympus Recalls Olympus High Flow Insufflation Unit Due to Over-Inflationįresenius Medical Care Recalls Some Hemodialysis Machines for Potential Exposure to Toxic Compounds ![]() Teleflex, and Arrow International, Recall Pressure Injectable Catheter Kits for Mislabeling The list below contains recalls that were issued in 2023.
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