Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs
Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA
FDA MedWatch: Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death
HHS Statement Regarding the Cyberattack on Change Healthcare
Do Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes – FDA Safety Communication
FDA Medical Device Recall Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe Pump Due to Issues Associated with Earlier Software Versions
Prolia (denosumab): Drug Safety Communication - FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease

 

FDA Drug Safety Communications

Patients on Dialysis or with Mineral and Bone Disorder at Highest Risk

KCER Release Date: January 19, 2024

FDA MedWatch: Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference

 

FDA Medical Device Recall

Hospira, Inc. Issues A Voluntary Nationwide Recall For 4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection Due to the Potential Presence of Glass Particulate Matter

 

FDA Medical Device Recall

KCER Release Date: December 27, 2023

To: KCER Distribution list- including ESRD Network EDs and QIDs

Summary

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