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AC Power Adapter (Physio-Control) – battery charging issue (2023)

AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.

High

FDANov 6, 2023Nationwide• Physio-Control, Inc.

Merit Pursue Microcatheter (Merit Medical) – sterility risk (2023)

The sterility of microcatheter and infusion system devices cannot be guaranteed.

Very High

FDANov 6, 2023Nationwide• Merit Medical Systems, Inc.

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AC Power Adapter (Physio-Control) – battery charging issue (2023)

Merit Pursue Microcatheter (Merit Medical) – sterility risk (2023)

Field Cric Kit (Sarnova) – tube holder incompatibility (2023)

Merit Maestro Microcatheter (Merit Medical) – sterility risk (2023)

Cricothyrotomy Field Kit (Sarnova) – tube holder incompatibility (2023)

SEROLOGY ToRCH lgM (Randox) – reactivity decrease (2023)

ENDOEYE HD II Videoscope (Olympus) – image coloration (2023)

Sterile Water/Saline (Nurse Assist) – sterility concern (2023)

Sterile Water (Nurse Assist) – Sterility Concern (2023)

Sterile Water/Saline (Nurse Assist) – sterility concern (2023)

0.9% Sodium Chloride (Nurse Assist) – sterility concern (2023)

CARDIOHELP-i System (Maquet) – Factory Settings (2023)

Medical Drainage Bag (Remington) – label date error (2023)

Sterile Prep Stick (Medline) – non-sterile contents (2023)

LINQ II Cardiac Monitor (Medtronic) – signal interference (2023)

Sterile PVP (Medline) – non-sterile contents (2023)

Sterile Povidone (Medline) – non-sterile contents (2023)

Multi-Mode Stimulator (Liberty Medical) – incomplete warnings (2023)

Quantum Biliary Balloon Dilator (Wilson-Cook) – device nonconformity (2023)

Cobas Interface Module (Inpeco) – delayed tube processing (2023)