Cardiac Assist, Inc recalls SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components:…

Recall date

October 14, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0311-2022

FDA classification

Class III

Brand / firm

Cardiac Assist, Inc

Sold / distributed

US Distribution to states of: DC, MA, SC, and VA.

Why it was recalled

Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date)

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.