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2 Deaths Linked To Missing IFU For Cardinal Health Scalpel Used For Newborns

 
• By Shawn M. Schmitt

The Safety Scalpel N11 is a component of Cardinal Health’s Argyle UVC Insertion Tray, which was recalled because it didn’t include the scalpel’s instructions for use. The recall has been labeled high-risk class I by the US FDA.

Old lead letters forming the word RECALL

Two deaths have been linked to missing instructions for use (IFU) for a Cardinal Health Inc. scalpel used during childbirth.

The Safety Scalpel N11 is part of the company’s Argyle UVC Insertion Tray. The scalpel is used when “inserting an Umbilical Venous Catheter (UVC) into the umbilical artery or vein...

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