Cardiac Assist, Inc recalls SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary C
Recalled 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.
Hazard / Issue
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)
Issued by
FDA
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