FDA Device recall Z-2244-2021
Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811)
- FDA Device
- Class I
- terminated
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class I recall of Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811) by Cardinal Health 200, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2244-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-06-16 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
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.
Identifiers
| code_info | All lot codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2244-2021%22
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