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MEDWATCH: THE FDA SAFETY INFORMATION AND ADVERSE EVENT REPORTING PROGRAM

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MedWatch, the FDA’s medical product safety reporting program for health
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MedWatch receives reports from the public and when appropriate, publishes safety
alerts for FDA-regulated products such as:

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 * Biologics such as blood components, blood/plasma derivatives and gene
   therapies.
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Product Type Biologics Drugs Medical Devices
Year 2023202220212020201920182017
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DateSafety AlertProduct Type 08/04/2023 Dräger Issues Worldwide Voluntary Recall
Notification for Carina Sub-Acute Care Ventilators to Address Possible
Contamination of the Breathing Gas with 1,3-Dichloropropan-2-olMedical Devices,
Potential Foreign Material08/01/2023Baxter 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
AlarmsMedical Devices07/31/20232023 Letters to Health Care ProvidersMedical
Devices, Radiation-Emitting Products07/31/20232023 Medical Device RecallsMedical
Devices07/31/2023Abbott Trifecta Valves: Potential Risk of Early Structural
Valve Deterioration - Letter to Health Care ProvidersMedical
Devices07/31/2023Baxter Issues Urgent Medical Device Correction for Spectrum V8
and Spectrum IQ Infusion Pumps with Specific Software VersionsDefect, Medical
Devices07/31/2023Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall
of 2 Lots of Tydemy™ (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium
Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) Due to Out
of Specification (OOS) Results at the 12-month Stability Time PointDrugs,
Impurity07/28/2023GE HealthCare Recalls TruSignal SpO2 Sensors for Issues That
May Reduce Defibrillation Energy, Expose Patients to Unintended Voltage, or Give
Inaccurate ReadingsMedical Devices07/27/2023Abiomed Recalls All Impella Left
Sided Blood Pumps for Risk of Motor Damage After Contact with Transcatheter
Aortic Valve Replacement (TAVR) StentMedical Devices07/26/2023Abbott Recalls
Amplatzer Steerable Delivery Sheath for Increased Risk of Air Embolism

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