PlainRecalls
FDA Devices Critical Class I Terminated

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

Reported: August 25, 2021 Initiated: June 16, 2021 #Z-2244-2021

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
7197 units
Distribution
US Nationwide distribution.
Location
Mansfield, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by Cardinal Health 200, LLC. Units affected: 7197 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 25, 2021. Severity: Critical. Recall number: Z-2244-2021.