ambIT Ambulatory Infusion Pump Cassette; Filter, Male, Sterile, Vol. 2.3ml, REF 220266, Sorenson Medical, Inc., West Jor
FDA device recall Z-0187-2007 · posted 2006-11-16 · Terminated
Recall details
- Recalling firm
- Sorenson Medical, Inc.
- Reason for recall
- Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
- Action taken
- Consignees were notified by letter on 10/10-11/2006 and told to immediately discontinue use/quarantine all affected cassettes. .
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 2000 units
- Distribution
- Worldwide, including USA, Belgium, France, Germany, Italy, Singapore, Venezuela.
- Date initiated
- 2006-10-10
- Date posted
- 2006-11-16
- Date terminated
- 2011-05-26
- 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 PUSH & PLAY AMBULATORY INFUSION PUMP (K052221) | Sorenson Medical, Inc. | 2005-12-08 |
| AMBIT CONTINUOUS AMBULATORY INFUSION PUMP (K033325) | Sorenson Medical, Inc. | 2003-11-06 |
| PALM PUMP (K002434) | Sorenson Medical, Inc. | 2000-08-23 |