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Showing 4181–4200 of 8393 results

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Prismalix OR Light System (Getinge) – Fall Risk (2023)

A potential for a light system to fall in the operating room.

FDANov 8, 2023Nationwide• Getinge Usa Sales Inc

PowerLEDII Light System (Getinge) – Fall Risk (2023)

A potential for a light system to fall in the operating room.

FDANov 8, 2023Nationwide• Getinge Usa Sales Inc

Volista OR Light System (Getinge) – Fall Risk (2023)

A potential for a light system to fall in the operating room.

High

FDANov 8, 2023Nationwide• Getinge Usa Sales Inc

Hanaulux HLX3000 Light System (Getinge) – Fall Risk (2023)

A potential for a light system to fall in the operating room.

FDANov 8, 2023Nationwide• Getinge Usa Sales Inc

Rolite OR Light System (Getinge) – Fall Risk (2023)

A potential for a light system to fall in the operating room.

FDANov 8, 2023Nationwide• Getinge Usa Sales Inc

Abiomed Introducer Kit (Abiomed) – Sterile Barrier (2023)

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

FDANov 7, 2023Nationwide• Abiomed, Inc.

Abiomed Introducer Kit (Abiomed) – Sterile Barrier (2023)

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis.

FDANov 7, 2023Nationwide• Abiomed, Inc.

Oscor Introducer Kit (Abiomed) – Sterile Barrier (2023)

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

FDANov 7, 2023Nationwide• Abiomed, Inc.

Abiomed Oscor Introducer Kit (Abiomed) – Sterile Barrier (2023)

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

FDANov 7, 2023Nationwide• Abiomed, Inc.

Medical System (GE) – Bolt Torque Issue (2023)

GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly.

FDANov 7, 2023Nationwide• GE Hangwei Medical Systems, Co. LTD West Area Bldg. 3, No.1 Yongchang North Road 1 Yongchangbeilu; Beijing Economic and Technological Development Area Beijing China

NIM TriVantage EMG Tube (Medtronic) – Monitoring Issues (2023)

Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,

FDANov 7, 2023Nationwide• Medtronic Xomed, Inc.

Abiomed Introducer Kit (Abiomed) – Sterile Barrier (2023)

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

FDANov 7, 2023Nationwide• Abiomed, Inc.

Abiomed Introducer Kit (Abiomed) – Sterile Barrier (2023)

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

FDANov 7, 2023Nationwide• Abiomed, Inc.

Abiomed Introducer Kit (Abiomed) – Sterile Barrier (2023)

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

FDANov 7, 2023Nationwide• Abiomed, Inc.

Oscor Introducer Kit (Abiomed) – Sterile Barrier (2023)

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

FDANov 7, 2023Nationwide• Abiomed, Inc.

VERIGENE Utility Tray (Luminex) – Defective Components (2023)

Potentially defective utility trays in the reagent kits.

FDANov 7, 2023Nationwide• Luminex Corporation

Navik 3D v2 (APN Health) – IFU Update (2023)

IFU update

FDANov 7, 2023Nationwide• APN Health LLC

Abiomed Axillary Introducer (Abiomed) – Sterile Barrier (2023)

Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis

FDANov 7, 2023Nationwide• Abiomed, Inc.

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

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

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

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

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

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

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