Avalon Elite Vascular Access Kit — Class II medical device recall Z-1603-2020
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2020-04-08, distributed in AL, AZ, CA, CT, FL, GA, IL, MA…. A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle p
| Recall number | Z-1603-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2020-02-20 |
| Classified | 2020-03-27 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2022-01-18 |
| Distributed | AL, AZ, CA, CT, FL, GA, IL, MA, MI, NC, NH, NM, NY, OH, OK, TN, TX, VA |
| Quantity | 255 |
| UPC / GTIN / UDI-DI | 04037691831039 |
| Lot numbers | 19-03466 |
| Model numbers | 70106.3540 |
Product
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1603-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.