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Showing 6121–6140 of 11714 results

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Orchide 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

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

Hanaulux HLX2000 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

SugarMD Glucose Support Capsules (SUGARMDS) – Undeclared Medication (2023)

MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide

FDANov 8, 2023Nationwide• SUGARMDS LLC

Axcel 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

G8 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

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

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 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.

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 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

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

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 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.

Naproxen Tablets (Glenmark) – Labeling Mix-Up (2023)

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Class IIModerate

FDANov 7, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

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.

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