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

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

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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