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Design Options Epidural Kit (B. Braun) – Incorrect Filter Straw (2023)

Kits were assembled with the incorrect Filter Straw.

FDAJun 5, 2023Nationwide• B. Braun Medical, Inc.

Cardiosave Hybrid IABP (Datascope) – Power Board Failure (2023)

An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.

Moderate

FDAJun 5, 2023Nationwide• Datascope Corp.

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Design Options Epidural Kit (B. Braun) – Incorrect Filter Straw (2023)

Cardiosave Hybrid IABP (Datascope) – Power Board Failure (2023)

Mack LRBE Electric (MACK) – Power Cable Issue (2023)

Volvo VNRE Electric (VOLVO) – Power Cable Issue (2023)

Volvo VNL (VOLVO) – Side Curtain Airbag Circuit (2023)

Terex TL (TEREX) – Subframe Welding Defect (2023)

Autocar Legend (AUTOCAR) – Park Brake Warning Light (2023)

Cytosponge Cell Collection Device (Covidien) – Sponge Detachment Risk (2023)

International MV (INTERNATIONAL) – Brake Fluid Issue (2023)

Triple E RV Wonder (TRIPLE E RV) – Air Conditioning Wiring (2023)

IC Bus CESB (IC BUS) – Brake Fluid Leakage (2023)

DxA Automation System (Beckman Coulter) – Test Sample Compatibility (2023)

EGO Power+ Hedge Trimmers – Laceration hazard (2023)

PowerXL Self-Cleaning Juicers – Laceration risk (2023)

Megadyne MEGA SOFT Universal Electrode (Megadyne) – Patient Burn Risk (2023)

Spartan Fire Gladiator (SPARTAN FIRE) – Rope Rescue Anchor Point (2023)

Nova and Star 3-Wheel Scooters – Fall hazard (2023)

Megadyne MEGA 2000 Electrode (Megadyne) – Patient Burn Risk (2023)

Altec Aerial Device (ALTEC) – Collision Mitigation Software (2023)

Land Rover Discovery (LAND ROVER) – Entry System Malfunction (2023)