“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.”
EndoVive Safety PEG Kits 20 F || Universal Product Number (UPN): MOO566460 || The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.
Worldwide Distribution: USA, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Kuwait, Luxembourg, Netherlands, Norway, Panama, Poland, Portugal, Romania, Spain, Switzerland, and Ukraine.
Descripción del producto
Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303. [OUS Material Number (UPN) M001553000, Catalog Number 55-300]
AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
Descripción del producto
Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917511, Catalog # 1751, Material No. [Inner Pouch Label] H74917510. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
Descripción del producto
Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917521, Catalog # 1752, Material No. [Inner Pouch Label] H74917520. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.
AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN,MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, SI, WV, and WY. OUS locations to include: Balkans, Finland, Germany, Great Britain, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Romania, Saudia Arabia, Spain, Sweden, Switzerland, and United Arab Emirates
Descripción del producto
Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917531, Catalog # 1753, Material No. [Inner Pouch Label] H74917530. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been designed to provide torsional control. The guidewire has a shapeable and highly radiopaque distal platinum tip. Legal Manufacturer: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA.