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.
데이터 추가 비고
Kit, I.V. Start - Product Code LRS
원인
On march 26, 2013 covidien received a recall notice from one of their suppliers carefusion. carefusion is recalling a variety of otc drug products including the 10% povidone iodine sepp applicator which is utilized in specific convenience kits.
조치
US Customers were notified of the recall by letter sent by Federal Express on April 12, 2013. The letter requests that they immediately stop using any affected product, quarantine it, and return it to Covidien. Consignees were asked to return a verification form and return it to Covidien via fax.
“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.