Other Medical Devices

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Sterility assurance with procedure trays

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.