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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Cardiac Assist
- LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000
FDA Device · Class II · 2023-09-06 · Cardiac Assist - SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000
FDA Device · Class I · 2023-01-25 · Cardiac Assist - TANDEM LIFE LivaNova LIFESPARC Controller
FDA Device · Class I · 2022-10-05 · Cardiac Assist - Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization
FDA Device · Class II · 2021-05-05 · Cardiac Assist - TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory s…
FDA Device · Class II · 2020-05-20 · Cardiac Assist
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0311-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.