Categories
Intravascular PICC Catheter Recall: Bard Removes PowerPICC Intravascular Catheters
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Categories
Infusion Pump Software Recall: Baxter Removes Sigma Spectrum Infusion System Platforms
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Categories
Diagnostic Intravascular Catheter Recall: Conavi Removes Novasight Hybrid Catheters
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Categories
Custom Surgical Pack Recall: Alcon Removes Custom Pak Ophthalmic Procedure Packs
Alcon recalls Custom Pak Ophthalmic Procedure Packs due to incomplete seals that may compromise sterility. Check lot numbers, recall instructions.
Categories
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.
Categories
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
Categories
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
Categories
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
Categories
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.
Categories
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.
