Infant Ventilators with Electronic Manometer. Models IV-100B; IV-200 and IV-200 SAVI.
FDA device recall Z-1032-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Sechrist Industries Inc
- Reason for recall
- Electronic manometer malfunctions. Manometer may be illegible. The alarm for power failure may function only briefly, or not at all.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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, Thai
- Date initiated
- 2004-05-20
- Date posted
- 2004-07-20
- Date terminated
- 2006-03-14
- Location
- Anaheim, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SECHRIST IV-100B SAVI SYSTEM (K920121) | Sechrist | 1993-02-01 |
| MODEL IV 100B-DA INFANT VENTILATOR (K833982) | Sechrist Industries, Inc. | 1984-03-05 |
| SECHRIST INFANT VENTRILATOR MODEL IV-100 (K811141) | Sechrist Industries, Inc. | 1981-06-12 |