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Intravascular Administration Set Recall: ICU Medical Removes IV Gravity Burette Set
ICU Medical removes IV Gravity Burette Set due to the burette component missing an internal shut-off valve intended to stop fluid flow.
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Blood Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllers
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Anesthesia System Correction: GE HealthCare Updates Use Instructions for CareStation Anesthesia Systems
GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems
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FDA Finds Insufficient Data to Determine Safety of PFAS in Cosmetic Products
FDA Finds Insufficient Data to Determine Safety of PFAS in Cosmetic Products
http://www.fda.gov/news-events/press-announcements/fda-finds-insufficient-data-determine-safety-pfas-cosmetic-products
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Continuous Glucose Monitoring Software Correction: Dexcom Issues Correction for Dexcom G6 and G6 Pro Software
A defect was discovered in the Dexcom G6 and G6 Pro Android US CGM App version 1.15.0 that may cause the app to shut down unexpectedly.
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Gold Star Distribution Inc., Issues Recall of Certain FDA-Regulated Products in Three States Including Drugs, Devices, Cosmetics, Human Foods, and Pet Foods
Gold Star Distribution, Inc. (Gold Star or “the Company”) is recalling all FDA regulated products listed in this press release due to the presence of rodent and avian contamination.
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Early Alert: Convenience Kit Needle Issue from Integra LifeSciences
Integra LifeSciences is removing certain lots of Microsensor and Cerelink ICP Kits with potential corrosion stains on the included Tuohy Needle.
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Endovascular Graft Recall: Cook Medical Removes Zenith Alpha 2 Thoracic Endovascular Graft
Cook Medical is removing certain ZENITH ALPHA 2 THORACIC ENDOVASCULAR GRAFT proximal components because PTFE scrapings may enter the stent graft during deployment.
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MRI System Correction: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems
Siemens Healthineers is correcting 3 Tesla MRI systems including MAGNETOM and BioGraph mMR due to the potential for ice blockage in the magnet venting system
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Catheter Mount Recall: Draeger Removes ErgoStar Catheter Mounts
Drager is removing affected ErgoStar Cather Mounts due to cracks in the hose.
