FDAFDA · Food and drugs·Recall number Z-1603-2020
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Published April 8, 2020 · Recall initiated: February 20, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Distributor
- Domestic distribution only to the following states: AL AZ CA CT FL GA IL MA MI NC NH NM NY OH OK TN TX VA
- Lot
- Lot 19-03466
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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