Recall Z-0645-2018 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
Medtronic Perfusion Systems
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 Cardiotom
| Date | Jan 16, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | Medtronic sent an Urgent Medical Device Recall Letter dated January 16, 2018. Customer Actions: Please review your inventory for product affected by this issue. 1.) Immediately identify and quarantine all unused, non-expired, affected product in your inventory. 2.) Return all unused, affected product in your inventory to Medtronic by contacting Customer Service at 1-800-854-3570 Option 4, or accessing My Orders and referencing this communication to initiate a return and credit of unused product. Your Medtronic sales representative can assist you in the return of affected product as nece |
| Quantity | 8644 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K936003 | AFFINITY CVR Avecor Cardiovascular, Inc., Jun 20, 1994 |