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.
The heparin sodium usp used to manufacture blood collection tubes was produced with crude heparin containing over-sulfated chondroitin sulfate.
조치
Covidien sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to immediately stop using the product, and return it to the firm.
Distributors were instructed to notify their customers.
All customers were required to respond to the notice regardless of their remaining inventory.
Responses will be tracked for follow-up and effectiveness checks.
For Customers Service questions regarding this recall call 1-800-962-9888 option 1.
Worldwide Distribution - USA including AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KS, KY, MA, MI, MN, MO, MS, NC, ND, NE, NJ, NM, MV, MY, OH, OK, PA, SC, SD, TN, TX, WA, and WI and the country of Canada
“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.