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Argon Medical Devices, Inc Recall 89439

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

Argon Medical Devices, Inc Recall 89439 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0563-2022
Event ID89439
Event Description1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Product TypeDevices
DistributionUS Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
Quantity600 ea
Recall ReasonGuidewire 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.
Device Classification20220216
Device Code Info1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022 2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026
Center Classification Date20220204
Recall Initiation Date20220124
Recalling FirmArgon Medical Devices, Inc
Initial Notification Letter
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