TandemLife ECLS Procedure Kit — Class II medical device recall Z-1106-2020
Terminated recall by Cardiac Assist, Inc, reported 2020-02-19, distributed nationwide. The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
| Recall number | Z-1106-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiac Assist, Inc, Pittsburgh, PA, United States |
| Recall initiated | 2019-11-19 |
| Classified | 2020-02-07 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2020-10-07 |
| Distributed | Nationwide (US) |
| Quantity | 11 kits |
| UPC / GTIN / UDI-DI | 00814112020517 |
| Model numbers | 5740-2417 |
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 for recall
The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1106-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.