FDA Device recall Z-1106-2020
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to…
- FDA Device
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to… by Cardiac Assist, citing the kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1106-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-19 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cardiac Assist |
| Distribution | US |
Product
TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
Reason
The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
Identifiers
| code_info | Serial Number/UDI 141445/ (01)00814112020517(17)200825(11)190423(21)00141445, 141446/ (01)00814112020517(17)20082…Serial Number/UDI 141445/ (01)00814112020517(17)200825(11)190423(21)00141445, 141446/ (01)00814112020517(17)200825(11)190423(21)00141446, 141447/ (01)00814112020517(17)200825(11)190423(21)00141447, 141448/ (01)00814112020517(17)200825(11)190423(21)00141448, 141449/ (01)00814112020517(17)200825(11)190423(21)00141449, 141450/ (01)00814112020517(17)200825(11)190423(21)00141450, 141451/ (01)00814112020517(17)200825(11)190429(21)00141451, 141452/ (01)00814112020517(17)200825(11)190429(21)00141452, 141453/ (01)00814112020517(17)200825(11)190429(21)00141453, 141454/ (01)00814112020517(17)200825(11)190429(21)00141454, 141457/ (01)00814112020517(17)200825(11)190429(21)00141457 Expiration Date for all products - August 25, 2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1106-2020%22
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