“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.
Go to www.mmc.medtronic-diabetes.com/look to determine if you have recalled infusion sets. You will be prompted to enter the Ref and Lot number for all infusion set boxes in your possession. The website will then tell you which infusion sets are part of this recall and which are not.
Your REF and LOT numbers are listed on the labels as shown in attached file.