Z-2244-2021 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 25, 2021
- Initiation Date
- June 16, 2021
- Termination Date
- January 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7197 units
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.
Distribution Pattern
US Nationwide distribution.
Code Information
All lot codes