Worldwide Distribution - US including US: AK, AZ, CA, DE, FL, HI, IL, LA, MD. MA. MN, MS, MO, NE, NJ,. NHY, NC, ND, OH, OR, PAM TN, TX, VA, WA, WV, and WI. Internationally to Australia, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, France, Germany, Israel, Japan, Netherlands, Serbia, South Africa, and Switzerland.
Descripción del producto
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. || Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. || This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures
“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.