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 Kit
    • Model No. 70106.3540
    • UDI 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 18, 2022 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.