FDA Device recall Z-1603-2020
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
- FDA Device
- Class II
- terminated
- Published 2020-04-08
On 2020-04-08 the FDA classified a Class II recall of Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 by Maquet Cardiovascular Us Sales, citing 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 Ar….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1603-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-20 |
| Published | 2020-04-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | AL, AZ, CA, CT, FL, GA, IL, MA, MI, NC, NH, NM, NY, OH, OK, TN, TX, VA |
Product
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Reason
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.
Identifiers
| code_info | Lot 19-03466 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1603-2020%22
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