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VISERA Tracheal Intubation Videoscope (Olympus) – Reprocessing Compatibility (2023)

Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible

Low

FDAMay 26, 2023Nationwide• Olympus Corporation of the Americas

Abiomed Introducer Set (Abiomed) – Sidearm Detachment Risk (2023)

There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.

Moderate

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VISERA Tracheal Intubation Videoscope (Olympus) – Reprocessing Compatibility (2023)

Abiomed Introducer Set (Abiomed) – Sidearm Detachment Risk (2023)

Olympus Endoscope Reprocessor (Olympus) – Reprocessing Compatibility (2023)

Flexi-Set Endotracheal Tube (TELEFLEX) – Connector Disconnection (2023)

Preformed AGT Oral Tube (TELEFLEX) – Connector Disconnection (2023)

Slick Set Cuffed Tube (TELEFLEX) – Connector Disconnection (2023)

RUSCHELIT Tracheal Tube (TELEFLEX) – Connector Disconnection (2023)

Slick Set Uncuffed Tube (TELEFLEX) – Connector Disconnection (2023)

Flexiva Pulse ID 242 TracTip single Use Fiber-intended to... (Boston Scientific Corporation) – burn hazard (2023)

Flexiva Pulse ID-intended to be used as a device that tra... (Boston Scientific Corporation) – burn hazard (2023)

Flexiva Pulse 242 Single-Use Laser Fibers-intended to be ... (Boston Scientific Corporation) – burn hazard (2023)

Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregi... (Philips Respironics, Inc.) – there are errors present in the korea... (2023)

Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Tropo... (QUIDEL CARDIOVASCULAR INC) – raw material issue may cause cardiac ... (2023)

Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be... (Boston Scientific Corporation) – burn hazard (2023)

Flexiva Pulse 242 TracTip Single-Use Laser Fibers - inten... (Boston Scientific Corporation) – burn hazard (2023)

Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT r... (TELEFLEX LLC) – there are incomplete pre-cleaning ins... (2023)

Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/n... (TELEFLEX LLC) – reports of disconnection of the 15mm ... (2023)

Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF... (TELEFLEX LLC) – reports of disconnection of the 15mm ... (2023)

Endotracheal Tube oral/nasal Magill, High Volume, Low Pre... (TELEFLEX LLC) – reports of disconnection of the 15mm ... (2023)

Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor (TELEFLEX LLC) – there are incomplete pre-cleaning ins... (2023)