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

Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.

Moderate

FDANov 6, 2023Nationwide• Olympus Corporation of the Americas

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

It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.

High

FDANov 6, 2023Nationwide• Sarnova HC, Llc

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Allura Systems (Philips) – ceiling mount collision risk (2023)

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