USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
Description du dispositif
Oridion Surestream CO2 Sampling Lines- || SureLine O2 || Part Number: 010979-03 || Product Usage: || The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
“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.
USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
Description du dispositif
Oridion Surestream CO2 Sampling Lines- || Sure VentLine Set Adult/Pediatric || Part Number: 010986-03 || Product Usage: || The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
Description du dispositif
Oridion Surestream CO2 Sampling Lines- || SureLine Adult || Part Number: 010976-03 || Product Usage: || The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
Description du dispositif
Oridion Surestream CO2 Sampling Lines- || Smart SureLine Plus O2 adult || Part Number: 010981-03 || Product Usage: || The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
USA Nationwide Distribution including the states of: AZ, CA, FL, HI, LA, MA, MO, NJ, NY, OH, OR, TX and WI.
Description du dispositif
Oridion Surestream CO2 Sampling Lines- || Sure VentLine H Set Adult/Pediatric || Part Number: 010987-03 || Product Usage: || The intended use of SureStream sampling lines is to convey a sample of a patients expired breath to a capnograph in order to measure CO2 partial pressure in intubated and non intubated patients.
Oridion CO2 sampling lines and water traps under the label: || Omnistream CO2 Sampling Lines: || OmniLine O2 Adult Part No.007609; || OmniLine O2 Pediatric Part No 007610; || Smart OmniLine Plus O2 Adult Part No.010177; || Smart OmniLine Plus O2 Adult (package of 100 units) Part No.010213; || Smart OmniLine O2 Pediatric Part No. 007606; || ;Smart OmniBloc O2 Part No. 010946 || Smart OmniLine Plus part No. 010172 || Smart OmniLine Plus (package of 100 units) Part No 010212; || Smart OmniLine Guardian O2 Part No. 012531; || Smart OmniLine Guardian O2 Long Part No. 012532 || OmniVentLine Set Part No. 012495