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MONOCRYL Suture (Ethicon) – Packaging Sterility (2024)

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Low

FDAMay 10, 2024Nationwide• Ethicon, Inc.

HistoCore Arcadia H (Leica) – Smoke and Fire Hazard (2024)

Fire/Burn Risk

An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.

High

FDAMay 10, 2024Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

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MONOCRYL Suture (Ethicon) – Packaging Sterility (2024)

HistoCore Arcadia H (Leica) – Smoke and Fire Hazard (2024)

MONOCRYL Plus Antibacterial Suture (Ethicon) – Packaging Sterility (2024)

PDS II Suture (Ethicon) – Packaging Sterility (2024)

MRI Vantage Orian Systems (Canon Medical) – Cable Fastening Issue (2024)

VICRYL Suture (Ethicon) – Packaging Sterility (2024)

Xstar Safety Slit Knife (Beaver Visitec) – Blade Configuration Error (2024)

Exchangeable Needle Syringes (Sol-Millennium) – 510(k) Modification (2024)

Kosmos iOS Ultrasound (Echonous) – Measurement Inaccuracy (2024)

Luer Slip Tip Syringes (Sol-Millennium) – 510(k) Modification (2024)

Low Dead Space Syringes (Sol-Millennium) – 510(k) Modification (2024)

First Source iQ Flex M Cart (First Source) – Positioning Arm Risk (2024)

Philips Tempus LS Defibrillator (Remote Diagnostic) – ECG Interference (2024)

First Source Vision M Cart (First Source) – Positioning Arm Risk (2024)

Eccentric Tip Syringes (Sol-Millennium) – 510(k) Modification (2024)

Syringe Tip Caps (Sol-Millennium) – 510(k) Modification (2024)

Hoffman LRF Wire Tensioner (Stryker) – Adjustment Ring Issue (2024)

SureStep Foley Tray System (Bard) – Temperature Display Defect (2024)

Fixed Needle Syringes (Sol-Millennium) – 510(k) Modification (2024)

MEGADYNE MEGA SOFT Electrode (Megadyne) – Patient Burn Risk (2024)