Devon Light GloveItem Number and Item Description 571711 NS-3600-B LITE GLOVE31140208 3611 LITE GLOVE31140216 3613 LITEGLOVE CS19231140257 3612 THEATRE LITE GLOVELot numbers beginning with 508xxxx or lowerManufactured: March 2012 through March 2015ARTG number: 186761
“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.
Model: 2900456-0x, 2900846-0x, 2901816-0x, 2902500-0x, 2903916-0x, 2904409-0x, 2906757-00, 2908159-0x, 2908973-0x, Affected: All lot numbers ending xx2, xx3, xx4, and lot numbers 015, 025, 035, and 045 delivered before 6 May 2015