US/Silver Spring: Baxter International Inc., a Deerfield, Illinois establishment, issues an Urgent Medical Device Correction for certain batch/lots of Hillrom Life2000 Ventilation Systems from the American marketplace due to suspected in-use operational failure with consequential risks of patient Oxygen Desaturation (i.e., low blood oxygen) events that can occur under certain conditions when the Life2000 system is connected with a third-party Oxygen Concentrator, all serious health and safety hazards requiring immediate medical intervention to minimize pain and suffering as well as prevent life-altering injury or death.
Additional information:
The US Food and Drug Administration (“FDA”) reports the following Medical Devices are subject to this recall:
Filed under: Home & Residential, Labeling or regulatory issues, Medical / Veterinary, Portable Oxygen Concentrators, US FDA | Tagged: Baxter International Inc., cardiac arrest hazard, choking hazards, Hillrom, Hillrom Life2000 Ventilation Systems, Oxygen Concentrators., Recalls Direct RIN: 16883-2023, Respiratory Failure hazard, US FDA, US Food and Drug Administration | Leave a comment »