FDAFDA · Food and drugs·Recall number Z-0563-2022
1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Published February 16, 2022 · Recall initiated: January 24, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Argon Medical Devices, Inc
- Distributor
- US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
- Lot
- 1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022 2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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