Recall Z-0826-2017 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Medtronic Inc
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or
| Date | Dec 20, 2016 (initiated Nov 16, 2016) |
| Status | Terminated |
| Reason | Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator. |
| Root cause | Process control |
| Action | The firm, Medtronic, sent an "Urgent Medical Device Recall" letter dated November 2016 to its Consignees on 11/16/2016. The letter was addressed to Risk Manager or Healthcare Professional. The letter described the problem and the product involved in the recall and actions to be taken. The consignees were instructed to quarantine all unused affected product in your inventory, return the affected product (contact Medtronic Customer Service at 800-848-9300 to initiate a product return) and complete & return the Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the att |
| Quantity | 5609 (663 US; 4946 OUS) |
| Distribution | Worldwide Distribution-US (nationwide) in states of: AK, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, LA, MN, ND, NV, NY, SD, TN, TX, WI, WY and countries of: Canada, Chile, Croatia, Germany, Greece, Hungary, Iran, Italy, Latvia, Lebanon, Poland, Portugal, Romania, Spain, Tanzania, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132972 | AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE Medtronic, Inc., Oct 28, 2013 |
| K142784 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integ Medtronic, Inc., Oct 24, 2014 |
| K924529 | SIGNATURE(TM) CUSTOM TUBING PACK Avecor Cardiovascular, Inc., Jun 23, 1993 |