1 — Class II medical device recall Z-0563-2022
Ongoing recall by Argon Medical Devices, Inc, reported 2022-02-16, distributed nationwide. Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This
| Recall number | Z-0563-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argon Medical Devices, Inc, Athens, TX, United States |
| Recall initiated | 2022-01-24 |
| Classified | 2022-02-04 |
| Reported by FDA | 2022-02-16 |
| Distributed | Nationwide (US) |
| Quantity | 600 units |
| Serial numbers | 11377499, 11378381 |
| Model numbers | 400115A, 498100 |
Product
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Reason for recall
Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.
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-0563-2022. 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.