Recall Z-2244-2021— Cardinal Health 200, LLC
Class I · Terminated
Class I FDA medical device recall by Cardinal Health 200, LLC, initiated 2021-06-16, terminated 2023-01-04. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-06-16
- Terminated
- 2023-01-04
- Firm location
- Mansfield, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.