CLASS II ONGOING Device recall · Reported 16 Feb 2022 · FDA Enforcement Report
Arterial Line Kit Arterial Line Kit /1 recalled by Argon Medical Devices
Argon Medical Devices is recalling Arterial Line Kit Arterial Line Kit /1, distributed nationwide in the US. The recall was initiated on 24 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0563-2022
- FDA event ID
- 89439
- Recalling firm
- Argon Medical Devices, Athens, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jan 2022
- FDA classified
- 4 Feb 2022
- Reported
- 16 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Jan 2022 | Recall initiated by company | |
| 4 Feb 2022 | Classified by FDA | +11 days |
| 16 Feb 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Where it was distributed
US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
Nationwide AlabamaCaliforniaDelawareIllinoisIndianaLouisianaMontanaNevadaOhioTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022 2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026
Where was it sold?
US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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