Worldwide Distribution -- USA including DC, Puerto Rico and Guam and countries of United Arab Emirates Austria, Bosnia and Herzegovina, Bahrain, Switzerland, Germany, Egypt, Spain, Finland, France, Great Britain, Ireland, Italy, Kuwait, Netherland, Pakistan, Portugal, Saudi Arabia, Sweden, Slovak Republic, Tunisia, Turkey, South Africa, Netherlands, Costa Rica, Japan, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Macau, Malaysia, Mexico New Zealand, Panama, Peru, Philippines, Puerto Rico, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay, and Venezuela.
Description du dispositif
Boston Scientific, Flexima¿ and Percuflex¿ Drainage Catheter Family (Pigtail Style) || UPN# DESCRIPTION || M001201050 VSKCL-12 || M001201060 VSKCL-14 || M001202020 VSDCL-12 || M001202030 VSDCL-14 || M001203060 VSCL-12 || M001203070 VSCL-14 || Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. || Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.
“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.”
Worldwide Distribution -- USA including DC, Puerto Rico and Guam and countries of United Arab Emirates Austria, Bosnia and Herzegovina, Bahrain, Switzerland, Germany, Egypt, Spain, Finland, France, Great Britain, Ireland, Italy, Kuwait, Netherland, Pakistan, Portugal, Saudi Arabia, Sweden, Slovak Republic, Tunisia, Turkey, South Africa, Netherlands, Costa Rica, Japan, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Macau, Malaysia, Mexico New Zealand, Panama, Peru, Philippines, Puerto Rico, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay, and Venezuela.
Description du dispositif
Boston Scientific, Flexima¿ and Percuflex¿ Drainage Catheter Family (Pigtail Style) || UPN# DESCRIPTION || M001205501 SACKS SS/6FR/28CM (BX/5) || M001205521 SACKS SS/8.3FR/28CM (BX/5) || Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. || Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.
Worldwide Distribution -- USA including DC, Puerto Rico and Guam and countries of United Arab Emirates Austria, Bosnia and Herzegovina, Bahrain, Switzerland, Germany, Egypt, Spain, Finland, France, Great Britain, Ireland, Italy, Kuwait, Netherland, Pakistan, Portugal, Saudi Arabia, Sweden, Slovak Republic, Tunisia, Turkey, South Africa, Netherlands, Costa Rica, Japan, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Macau, Malaysia, Mexico New Zealand, Panama, Peru, Philippines, Puerto Rico, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay, and Venezuela.
Description du dispositif
Boston Scientific, Flexima¿ and Percuflex¿ Drainage Catheter Family (Pigtail Style) || UPN# DESCRIPTION || M001221000 AA/8/30 || M001221010 AA/10/30 || M001221020 AA/12/30 || Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. || Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.
Worldwide Distribution -- USA including DC, Puerto Rico and Guam and countries of United Arab Emirates Austria, Bosnia and Herzegovina, Bahrain, Switzerland, Germany, Egypt, Spain, Finland, France, Great Britain, Ireland, Italy, Kuwait, Netherland, Pakistan, Portugal, Saudi Arabia, Sweden, Slovak Republic, Tunisia, Turkey, South Africa, Netherlands, Costa Rica, Japan, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Macau, Malaysia, Mexico New Zealand, Panama, Peru, Philippines, Puerto Rico, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay, and Venezuela.
Description du dispositif
Boston Scientific, Flexima¿ and Percuflex¿ Drainage Catheter Family (Pigtail Style) || UPN# DESCRIPTION || M001225240 VTC FIRM KIT 8 || M001225140 VTC FIRM 8 || Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. || Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.
Worldwide Distribution -- USA including DC, Puerto Rico and Guam and countries of United Arab Emirates Austria, Bosnia and Herzegovina, Bahrain, Switzerland, Germany, Egypt, Spain, Finland, France, Great Britain, Ireland, Italy, Kuwait, Netherland, Pakistan, Portugal, Saudi Arabia, Sweden, Slovak Republic, Tunisia, Turkey, South Africa, Netherlands, Costa Rica, Japan, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Macau, Malaysia, Mexico New Zealand, Panama, Peru, Philippines, Puerto Rico, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay, and Venezuela.
Description du dispositif
Boston Scientific, Flexima¿ and Percuflex¿ Drainage Catheter Family (Pigtail Style) || UPN# DESCRIPTION || M0064102020 Percuflex All Purpose Drainage Catheters || wit Fader Tip and Locking Pigtail 8 Fr || M0064102030 Percuflex All Purpose Drainage Catheters with Fader || Tip and Locking Pigtail 10 Fr || Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. || Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.
Worldwide Distribution -- USA including DC, Puerto Rico and Guam and countries of United Arab Emirates Austria, Bosnia and Herzegovina, Bahrain, Switzerland, Germany, Egypt, Spain, Finland, France, Great Britain, Ireland, Italy, Kuwait, Netherland, Pakistan, Portugal, Saudi Arabia, Sweden, Slovak Republic, Tunisia, Turkey, South Africa, Netherlands, Costa Rica, Japan, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Macau, Malaysia, Mexico New Zealand, Panama, Peru, Philippines, Puerto Rico, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay, and Venezuela.
Description du dispositif
Boston Scientific, Flexima¿ and Percuflex¿ Drainage Catheter Family (Pigtail Style) || UPN# DESCRIPTION || M0064101260 Percutaneous Combination Stent/Nephrostomy Catheter 8 Fr || Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. || Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.