Reported Apr 8, 2020 · Terminated
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Maquet Cardiovascular US Sales, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
Avalon Elite Vascular Access KitModel No. 70106.3540UDI 04037691831039
- Lot codes and dates
- Lot 19-03466
- Amount recalled
- 255
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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