U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Medtronic is initiating a voluntary product recall for specific lot numbers of the affinity fusion¿ oxygenators with balance¿1 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.
조치
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.
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.
제품 설명
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 Balance¿1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.