Recall Z-0857-2010 ยท CBK Ventilator, Continuous, Facility Use
CareFusion 203, Inc.
Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341. Intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
| Date | Feb 25, 2010 (initiated Jan 8, 2010) |
| Status | Terminated |
| Reason | CareFusion is recalling the EnVe Ventilator because the EnVe Ventilator does not fully meet applicable standards for immunity to electro-Magnetic Interference (EMI) when tested in the laboratory environment. CareFusion has identified certain device malfunctions that may affect device performance and patient safety in the intended use environment. |
| Root cause | Component design/selection |
| Action | CareFusion issued an "Urgent Medical Device Recall notification" letter dated January 07, 2010. The letter was addressed to the Director of Respiratory Care describing the problem and the product. Consignees were told that a Service Representative will contact them to arrange for the prompt return of the affected product for correction. For further information, contact CareFusion Technical Support at 1-800-231-2446, Option 1. |
| Quantity | 9 |
| Distribution | MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070594 | PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 Pulmonetic Systems, Inc., Aug 1, 2007 |