Large-Volume IV Administration Sets for use with Deltec 3000 and Deltec Micro 3100 Large Volume Infusion Pumps. ------Mo
FDA device recall Z-0659-06 · posted 2006-03-18 · Terminated
Recall details
- Recalling firm
- Smiths Medical MD, Inc.
- Reason for recall
- Inaccurate infusion rate-administration sets which are used with selected infusion pumps may have a defect which does not allow the pump valve to close completely.
- Action taken
- Affected customers were notified of the recall and asked to return or destroy any unused product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 4 boxes of 40 Admin. Sets (160 sets in total)
- Distribution
- South Carolina, Australia, Canada and Puerto Rico.
- Date initiated
- 2005-12-08
- Date posted
- 2006-03-18
- Date terminated
- 2007-01-05
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CADD ADMINISTRATION SET (K991599) | Sims Deltec, Inc. | 1999-06-15 |
| GUARDIAN, VOLUMETRIC CONTROL DELIVERY (K811933) | Avi, Inc. | 1981-07-20 |