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MultiLab Series II ROODRA (Unetixs) – Air Embolism Risk (2023)

The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.

Moderate

FDAFeb 10, 2023Nationwide• Unetixs Vascular, Inc.

MultiLab Series II LHS (Unetixs) – Air Embolism Risk (2023)

The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.

Moderate

FDAFeb 10, 2023Nationwide• Unetixs Vascular, Inc.

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MultiLab Series II ROODRA (Unetixs) – Air Embolism Risk (2023)

MultiLab Series II LHS (Unetixs) – Air Embolism Risk (2023)

MultiLab Series II 2CP (Unetixs) – Air Embolism Risk (2023)

da Vinci Surgical System (Intuitive) – Manipulator Component Issue (2023)

MultiLab Series II REVO (Unetixs) – Air Embolism Risk (2023)

Shiley Tracheal Tube (Covidien) – Inflation System Leak (2023)

DeRoyal Suction Canister (DeRoyal) – Lid Shrinkage Concern (2023)

Medtronic Grafton DBF Inject (Medtronic) – Packaging Concern (2023)

Medtronic Grafton Putty (Medtronic) – Packaging Concern (2023)

Medtronic Grafton Orthoblend (Medtronic) – Packaging Concern (2023)

Medtronic Grafton Matrix Strips (Medtronic) – Packaging Concern (2023)

Medtronic Grafton Crunch (Medtronic) – Packaging Concern (2023)

Medtronic Accelerate Grafton DBF (Medtronic) – Packaging Concern (2023)

Medtronic Grafton Flex (Medtronic) – Packaging Concern (2023)

Medtronic Grafton DBF (Medtronic) – Packaging Concern (2023)

Medtronic Grafton Matrix (Medtronic) – Packaging Concern (2023)

Medtronic Grafton Gel (Medtronic) – Packaging Concern (2023)

Medtronic Grafton Plus Paste (Medtronic) – Packaging Concern (2023)

Medtronic XPANSE Bone Insert (Medtronic) – Packaging Concern (2023)

Cardiosave Hybrid IABP (Datascope) – Helium Tank Leak Risk (2023)