Recall Z-1032-04 ยท CBK Ventilator, Continuous, Facility Use
Sechrist Industries Inc
Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI.
| Date | Jul 20, 2004 (initiated May 20, 2004) |
| Status | Terminated |
| Reason | Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all. |
| Root cause | Other |
| Action | Recall notification contains a test method to be used to identify defective units. Return notification that ventilator is defective will result in replacement of the electronic manometer. |
| Quantity | 240 |
| Distribution | Nationwide and to Malaysia, Japan, Kuwait, Sri Lanka, South Africa, Guatemala, Mexico, Morocco, Indonesia, Korea, Ecuador, Colombia, Portugal, Oman, Switzerland, Spain, Zimbabwe, Belgium, Brazil, Thailand, Argentina, Costa Rica, Taiwan, ROC, India, Russia, Saudi Arabia, Pakistan, Caribbean, Venezuel |
| FDA record | Open on fda.gov |