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Ivenix Infusion System (Fresenius) – Software Anomalies (2024)

The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.

Very High

FDAAug 30, 2024Nationwide• Fresenius Kabi USA, LLC

LIFEPAK 15 (Physio-Control) – Tool Tolerance Issue (2024)

Due to an out of tolerance tool being used on monitor/defibrillator systems.

High

FDAAug 30, 2024CT, GA, MA +4 more• Physio-Control, Inc.

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Ivenix Infusion System (Fresenius) – Software Anomalies (2024)

LIFEPAK 15 (Physio-Control) – Tool Tolerance Issue (2024)

Monarch Inflation Device (Merit) – Sterile Barrier Breach (2024)

Melrose Injector (Merit) – Sterile Barrier Breach (2024)

Monarch Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Centricity Universal Viewer (GE Healthcare) – Reporting Problem (2024)

Hemo-7 Hemospray (Wilson-Cook) – Raw Material Nonconformance (2024)

BIOFINITY XR TORIC Lenses (CooperVision) – Misaligned Axis (2024)

Stryker Tornier Perform Humeral System (Tornier) – Locking Ring Issue (2024)

Tornier Perform Humeral System (Stryker) – Endotoxin Load (2024)

Kara Boondhi (Grace Imports) - Undeclared Wheat (2024)

Spicy Murukku Ingredients (Grace Imports) - Undeclared Wheat (2024)

Kerala Mixture (Grace Imports) - Undeclared Wheat (2024)

Biofinity Toric Multifocal Lenses (CooperVision) – Misaligned Axis (2024)

Good Vibrations Ultrasonic Cleaner (Microcare) – Bacterial Contamination (2024)

Medline Heart CABG CDS (MEDLINE) – Cannulae Component Risk (2024)

Medline Laparoscopy Pack (MEDLINE) – Endo Pocket Concern (2024)

Medline Open Heart (MEDLINE) – Cannulae Component Risk (2024)

Medline Kit CV I II (MEDLINE) – Cannulae Component Risk (2024)

Medline Open Heart NIMC Kit (MEDLINE) – Cannulae Component Risk (2024)