Maquet recalls Avalon Elite Vascular Access Kit model 70106.3540 due to incorrect arterial needle included in some kits. Affected kits may cause injury if used improperly.
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.
Take action
Contact the company
📍Recalling firmMaquet Cardiovascular Us Sales, Llc45 Barbour Pond Dr · Wayne, NJ 07470-2094
“Maquet Avalon Elite Vascular Kit Recall: Incorrect Needle Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65801-maquet-avalon-elite-vascular-kit-recall-incorrect-needle-risk. Based on FDA recall #Z-1603-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1603-2020%22&limit=1).
The FDA announced on Feb. 20, 2020, that Maquet Cardiovascular Us Sales, Llc is recalling Avalon Elite Vascular Access Kits due to a material mix-up in the needle portion. The agency said 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle.
How to tell if you have it
Brand: Maquet
Product: Avalon Elite Vascular Access Kit
Model No.: 70106.3540
UDI: 04037691831039
Lot: 19-03466
The hazard
The recall involves a material mix-up with the needle portion of the kit. According to the FDA, 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle.
Context
GovInfoNow's records show Maquet Cardiovascular Us Sales, Llc has 14 other recalls on record since Oct. 25, 2018. Other recent recalls include the Maquet HLS Set Advanced 7.0 Recall (Nov. 20, 2020), the Maquet BMU 40 Blood Monitor Recall (Sept. 30, 2020), and the Maquet Yuno II Mobile Operating Table Recall (Sept. 24, 2020). Other recent recalls of similar products include the AVID Medical Halyard Kits Recall (April 30, 2026) and the Arrow Echogenic Introducer Needle Recall (March 11, 2026).
How to tell if you have this one
Check for model number 70106.3540 and lot number 19-03466 on the kit. The recall affects kits sold with UDI 04037691831039.
Brand
Maquet
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for model number 70106.3540 and lot number 19-03466 on the kit packaging.
Where it went and when
Where it was distributed
Distributed in 18 states.
Listed by the agency
Not listed
FDA distribution: “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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Michigan, New Hampshire, New Mexico, New York, North Carolina, Ohio, Oklahoma, Tennessee, Texas, Virginia.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1603-2020 (February 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1603-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.