FDA Device recall Z-0311-2022
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass
- FDA Device
- Class III
- ongoing
- Published 2021-12-08
On 2021-12-08 the FDA classified a Class III recall of SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass by Cardiac Assist, citing 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/….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0311-2022 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2021-10-14 |
| Published | 2021-12-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardiac Assist |
| Distribution | DC, MA, SC, VA |
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.
Reason
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)
Identifiers
| code_info | Serial Numbers: 872170, 872171, 872172, 872173, 872182, 872183, 872184. UDI: 01)00814112020791(17)220 501(2…Serial Numbers: 872170, 872171, 872172, 872173, 872182, 872183, 872184. UDI: 01)00814112020791(17)220 501(22)220511(21) 872170; (01)00814112020791(17)220 501(22)220511(21) 872171; (01)00814112020791(17)220 501(22)220511(21) 872172; (01)00814112020791(17)220 501(22)220511(21) 872173; (01)00814112020791(17)220 501(22)220511(21) 872182; (01)00814112020791(17)220 501(22)220511(21) 872183; 01)00814112020791(17)220 501(22)220511(21) 872184 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0311-2022%22
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