Argyle UVC Insertion Tray containing Safety Scalpel N11 — Class I medical device recall Z-2244-2021
Terminated recall by Cardinal Health 200, LLC, reported 2021-08-25, distributed nationwide. The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The S
| Recall number | Z-2244-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Mansfield, MA, United States |
| Recall initiated | 2021-06-16 |
| Classified | 2021-08-16 |
| Reported by FDA | 2021-08-25 |
| Terminated | 2023-01-04 |
| Distributed | Nationwide (US) |
| Quantity | 7,197 units |
| Model numbers | 73-1811 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2244-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.