FDA Device recall Z-0563-2022
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
- FDA Device
- Class II
- ongoing
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class II recall of 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" by Argon Medical Devices, citing 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 b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0563-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-24 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Argon Medical Devices |
| Distribution | US |
Product
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Reason
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.
Identifiers
| code_info | 1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022 2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0563-2022%22
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