“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.”
Within the US to GA, MS, NC ,TN. OUS to include: Canada, Hong Kong, Italy, Netherlands, Saudi Arabia, United Kingdom
Description du dispositif
Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacturer: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311.
Within the US to GA, MS, NC ,TN. OUS to include: Canada, Hong Kong, Italy, Netherlands, Saudi Arabia, United Kingdom
Description du dispositif
Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacture: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311
Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Voda Left Curve, UPN # H74934356710, Catalog # 34356-71. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.