Z-1032-04

Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI

Name: Z-1032-04 Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI
Creator: Sechrist Industries Inc
Published: 2004-05-20
License: https://open.fda.gov/license/

Sechrist Industries Inc / initiated 2004-05-20 / Terminated

FDA source

Sechrist Industries Inc began a recall of Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI on 2004-05-20. The reason FDA records is "Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1032-04
Status: Terminated
Initiated: 2004-05-20
Posted: 2004-07-20
Terminated: 2006-03-14
Recalling firm: Sechrist Industries Inc
Product: Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI.
Product code: CBK Ventilator, Continuous, Facility Use
Reason for recall: Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all.
FDA 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 in commerce: 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, Venezuela.
Product codes and lots: Restricted to those ventilators with production serial numbers beginning with a ''00'' prefix.

Product code CBK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)