Fresenius Kabi is correcting Ivenix LVP software due to anomalies that could cause serious patient harm or death
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SKNV. Pompano Beach, FL. Untitled Letter issued 09/16/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/16/2025
Short Title (70 char) SKNV. Pompano Beach, FL. Untitled Letter issued 09/16/2025
FEI Number 3012384835
Firm Name SKNV
Record Type Untitled Letter
State FL
Establishment Type Outsourcing FacilityPDUFA Performance Reports
PDUFA Performance ReportsMediNatura New Mexico, Inc. Issues Voluntary Nationwide Recall of ReBoost Nasal Spray Due to Microbial Contamination
FOR IMMEDIATE RELEASE – December 10, 2025 – Albuquerque, New Mexico, MediNatura New Mexico, Inc. is voluntarily recalling one lot of ReBoost Nasal Spray to the consumer level. The product has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, aOlympus Announces Voluntary Corrective Action for the Single-Use Ligating Device
Center Valley, Pa., (December 5, 2025)-Olympus Corporation today announced a voluntary medical device corrective action for its Single-Use Ligating Device (“Polyloop”) following identification of a potential safety issue.Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)
As part of the Accelerating Rare disease Cures (ARC) Program, CDER’s Rare Diseases Team inaugurated the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) initiative. Learn more.Bio Wellness 444 LLC – 709333 – 05/30/2025
Unapproved New Drugs/Misbranded