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Recall Observatory FDA recall evidence

Device product

1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"

Z-0563-2022

January 24, 2022

Class II

Product summary

Firm
Argon Medical Devices, Inc
Event
Event 89439
Status
Ongoing
Classification
Class II
Quantity
600 ea
Official record key
device-enforcement:Z-0563-2022

Official wording

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.

Code information: 1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022 2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026

Distribution pattern: US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.