FDA recall Z-1603-2020

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

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

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