Cardinal Health 200, LLC Recall 88266
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
Cardinal Health 200, LLC Recall 88266 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2244-2021 |
| Event ID | 88266 |
| Event 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 Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 7197 units |
| Recall 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 delay or death |
| Device Classification | 20210825 |
| Device Code Info | All lot codes |
| Center Classification Date | 20210813 |
| Recall Initiation Date | 20210616 |
| Recalling Firm | Cardinal Health 200, LLC |
| Initial Notification | Letter |
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