MicroStream Filterline Infant/Neonatal products: Part # 008598 - FILTERLINE H SET INF/NEO 25UN DRAEGER(Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. || The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.
“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.
MicroStream Filterline Infant/Neonatal products: Part # 006285 - FILTERLINE H SET INF/NEO 25 UN PHYSIO (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. || The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.
MicroStream Filterline Infant/Neonatal products: Part # 006324 - FILTERLINE H SET INF/NEO 25 UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. || The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.
Micro Stream Filterline Infant/Neonatal products: Part # 010807 - VlTALINE H SET INFANT/NEONATAL 25UN (Inf/Neo Airway Adapter). The adult/pediatric airway adapter and the adult/pediatric FilterLine and VitaLine sets are not affected by this recall. || The intended use of Microstream Filter Lines is to convey a sample of a patient's expired breath to a capnograph in order to measure the CO2 partial pressure in intubated patients. It is a component of the FilterLine H Set Inf/Neo, Part # 006324 and the VitaLine H Set Inf/Neo, Part # 010807.