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Press Release/Announcement

Cardinal Health recalls Argyle UVC insertion tray due to missing instructions for use for the Safety Scalpel N11.

Cardinal Health recalls Argyle UVC insertion tray due to missing instructions for use for the Safety Scalpel N11. MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 20, 2021.

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September 1, 2021

MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 20, 2021.

Delays in treatment due to device misuse or design flaws can result in patient harm. This recall announcement highlights the omission of instructions describing a distinct device feature that, if a surgeon is unaware of it, reduces emergent umbilical vein catheter placement safety. Two deaths have been reported due to problems with the device.

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Cardinal Health recalls Argyle UVC insertion tray due to missing instructions for use for the Safety Scalpel N11. MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 20, 2021.