Z-0646-2018 Class II Terminated
FDA device recall Z-0646-2018 was initiated by Medtronic Perfusion Systems on Jan 16, 2018 and is designated Class II. Reason for recall: Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products. The recall status is terminated (terminated Aug 21, 2020). Affected quantity: 3864 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 28, 2018
- Initiation Date
- Jan 16, 2018
- Termination Date
- Aug 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3864 units
Product Description
Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.
Reason for Recall
Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alone uncoated and Affinity NT Cardiotomy Venous Reservoir stand alone Trillium coated products.
Distribution Pattern
Worldwide Distribution - US Distribution and to the countries of : Australia, Canada, Colombia, Denmark, Germany, Guyana, Israel, Italy, Japan, Netherlands, Norway, Saudi Arabia and United Kingdom.
Code Information
All lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0646-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026