Recall Z-2244-2021 ยท FOS Catheter, Umbilical Artery
Cardinal Health 200, LLC
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
| Date | Aug 13, 2021 (initiated Jun 16, 2021) |
| Status | Terminated |
| 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. |
| Root cause | Labeling Change Control |
| Action | Cardinal Health issued Urgent Medical Device Correction letter and Acknowledgement Form on June 16, 2021 to the direct consignees. Letter states reason for recall, health risk and action to take: Actions Required: 1) REVIEW the IFU for the Safety Scalpel N11 (vendor part number 73-1811). 2) COMMUNICATE the IFU to all personnel that utilize the Argyle" UVC Insertion Tray (SKU 43201) containing Safety Scalpel N11 (vendor part number 73-1811) 3) NOTIFY any customers to whom you may have distributed/forwarded affected product or will send the product about this product correction notice and shar |
| Quantity | 7197 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.