Home / Recalls / Medical Devices
Cardiac Assist, Inc recalls SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a
Recalled December 8, 2021 · FDA recall Z-0311-2022 · Cardiac Assist
Hazard
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) · FDA Class III
Units
7 units
Sold at
US Distribution to states of: DC, MA, SC, and VA.
Description
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)
Product
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.
Manufacturer(s)
Cardiac Assist, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →