Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Avalon Elite Vascular Access Kit Recalled by Maquet Cardiovascular Us Sales, Llc Due to A lot of Avalon Elite Vascular Access Kits...

Date: February 20, 2020
Company: Maquet Cardiovascular Us Sales, Llc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Cardiovascular Us Sales, Llc directly.

Affected Products

Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039

Quantity: 255

Why Was This 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.

Where Was This Sold?

This product was distributed to 18 states: AL, AZ, CA, CT, FL, GA, IL, MA, MI, NH, NM, NY, NC, OH, OK, TN, TX, VA

Affected (18 states)Not affected

About Maquet Cardiovascular Us Sales, Llc

Maquet Cardiovascular Us Sales, Llc has 62 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report