Cardinal Health 200, LLC: Medical Device Recall in 2021 - (Recall #: Z-2244-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class I

Date Initiated: June 16, 2021

Date Posted: August 25, 2021

Recall Number: Z-2244-2021

Event ID: 88266

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.

Status: Terminated

Product Quantity: 7197 units

Code Information:

All lot codes

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated