Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubi
FDA device recall Z-0826-2017 · posted 2016-12-20 · Terminated
Recall details
- Recalling firm
- Medtronic Inc
- Reason for recall
- 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.
- Action taken
- 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 attention of Customer Focused Quality or scan and email to RS.CFQFCA@medtronic.com. For questions contact your Medtronic Representative. If you require assistance in contacting your representative, please contact Medtronics National Answering Service at 800-633-8766.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 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, Hunga
- Date initiated
- 2016-11-16
- Date posted
- 2016-12-20
- Date terminated
- 2017-08-01
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface (K142784) | Medtronic, Inc. | 2014-10-24 |
| AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE (K132972) | Medtronic, Inc. | 2013-10-28 |
| SIGNATURE(TM) CUSTOM TUBING PACK (K924529) | Avecor Cardiovascular, Inc. | 1993-06-23 |