Medtronic Perfusion Systems Recall: Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CV
Medtronic Perfusion Systems Recall: Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CV is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medtronic Perfusion Systems; Product: Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venou
| Recalling firm | Medtronic Perfusion Systems |
|---|---|
| Product | Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) 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(R) 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 |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | 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. |
| Recall initiated | 20180116 |
| Recall number | Z-0645-2018 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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