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SpinalPak Spine Fusion Stimulator (EBI) – Lead Wire Damage (2024)

Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment

Moderate

FDAMar 22, 2024Nationwide• EBI, LLC

Redux Electrolyte Creme (Parker Laboratories) – Low Viscosity (2024)

Product demonstrates low viscosity.

Low

FDAMar 22, 2024Nationwide• Parker Laboratories, Inc.

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SpinalPak Spine Fusion Stimulator (EBI) – Lead Wire Damage (2024)

Redux Electrolyte Creme (Parker Laboratories) – Low Viscosity (2024)

48" Lead Wires (EBI) – Wire Sheath Exposure (2024)

Med-Soft Single Liner with Solidifier (Medline) – Dimensional Variation (2024)

Artis Fluoroscopic X-Ray System (Siemens) – Cooling Circuit Failure (2024)

Neo SonarMed 3.5mm Sensor (SonarMed) – Obstruction Detection Failure (2024)

Neo SonarMed 3.0mm Sensor (SonarMed) – Obstruction Detection Failure (2024)

Neo SonarMed 2.5mm Sensor (SonarMed) – Obstruction Detection Failure (2024)

Expo 5F Angiographic Catheters (Boston Scientific) – Guidewire Advancement Issue (2024)

Baxter Spectrum IQ Infusion Pump (Baxter) – Improper Testing (2024)

Perseus A500 Anesthesia Workstation (Draeger) – Battery Power Shutdown (2024)

Alinity m System (Abbott) – Sample Rack Detection Problem (2024)

Durapore Surgical Tape (3M) – Incorrect Shelf Life Label (2024)

24K Premium Lens (Ontact) – Bacterial Contamination (2024)

ZPLP Distal Lateral Fibular Plate (Zimmer) – Locking Screw Mating Issue (2024)

ZPLP Distal Lateral Fibular Plate (Zimmer) – Locking Screw Mating Issue (2024)

Trilogy Evo Universal Ventilator (Philips) – Power Alarm Malfunction (2024)

Garbin EVO Ventilator (Philips) – Power Alarm Malfunction (2024)

LifeVentEVO2 Ventilator (Philips) – Power Alarm Malfunction (2024)

Cardioplegia Adapters (Medtronic) – Sterile Packing Issue (2024)