Recall Z-1106-2020— Cardiac Assist, Inc
Class II · Terminated
Class II FDA medical device recall by Cardiac Assist, Inc, initiated 2019-11-19, terminated 2020-10-07. It names one FDA 510(k) clearance: K162214. 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..
- Recalling firm
- Cardiac Assist, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-19
- Terminated
- 2020-10-07
- Firm location
- Pittsburgh, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.