# FDA recall Z-1603-2020

> **Maquet Cardiovascular Us Sales, Llc** · Class II · device recall initiated 2020-02-20.

## 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.

## 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

## Key facts

- **Recall number:** Z-1603-2020
- **Recalling firm:** Maquet Cardiovascular Us Sales, Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-20
- **Report date:** 2020-04-08
- **Termination date:** 2022-01-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1603-2020

## Citation

> AI Analytics. FDA recall Z-1603-2020. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1603-2020. Source: US FDA. Licensed CC0.

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