ambIT Ambulatory Infusion Therapy Intermittent Pump
FDA device recall Z-1188-06 · posted 2006-07-01 · Terminated
Recall details
- Recalling firm
- Sorenson Medical, Inc.
- Reason for recall
- Intermittent Infusion pump may continually dispense medication under certain conditions.
- Action taken
- All direct accounts were contacted by email and phone on 05/03/2006. Distributors were instructed to identify end users for Recalling Firm notification
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 72 pumps
- Distribution
- Worldwide distribution (including-states of IL, KS, NJ, PA, WA. , countries of Germany, Malaysia, New Zealand, Slovenia.
- Date initiated
- 2006-05-03
- Date posted
- 2006-07-01
- Date terminated
- 2006-08-09
- Location
- West Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMBIT INTERMITTENT AMBULATORY INFUSION PUMP (K033425) | Sorenson Medical, Inc. | 2003-11-06 |