FDA-Device2021-08-25Class I
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
Cardinal Health 200, LLC
Hazard
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.
Sold states
US Nationwide distribution.
Affected count
7197 units
Manufactured in
15 Hampshire St Bldg 5, N/A, Mansfield, MA, United States
Products
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2244-2021Don't want to check this manually?
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