Worldwide Distribution -- United States (AZ, AR, CO, DE, FL, GA, MI, MT, NE, NC, OH and WI), Spain, Finland and Netherlands.
Description du dispositif
Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M001272600, Use before 2011-11, Sterilized with Ethylene Oxide Gas, Single Use Only, Made in USA 780 Brookside Drive, Spencer, IN 47460-1080. || The catheter is designed for external and internal percutaneous drainage of the biliary system.
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”