Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.
FDA device recall Z-1445-06 · posted 2006-08-26 · Terminated
Recall details
- Recalling firm
- Delphi Medical Systems
- Reason for recall
- Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.
- Action taken
- Distributors were notified via letter dated 3/29/05 instructing them to retrieve and return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 22 US and 147 international.
- Distribution
- Florida, Austria, Denmark, Finland, Germany, Norway, Sweden, Switzerland and United Kingdom.
- Date initiated
- 2006-03-29
- Date posted
- 2006-08-26
- Date terminated
- 2006-10-16
- Location
- Troy, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS (K953896) | Imed Corp. | 1996-03-20 |