FDA-Device2022-02-16Class II

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

Argon Medical Devices, Inc
Hazard

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.

Sold states
US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
Affected count
600 ea
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0563-2022

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