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.
Other recalls by Argon Medical Devices
- L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539
FDA Device · Class II · 2026-08-05 · Argon Medical Devices - L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
FDA Device · Class II · 2026-08-05 · Argon Medical Devices - General Biospy Tray, REF: GUTS1000
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - Arterial Line Kit 20ga x 6, REF: 400115A
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
FDA Device · Class I · 2026-07-22 · Argon Medical Devices
All Argon Medical Devices recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0563-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.