Recall Z-0188-2007 ยท FRN Pump, Infusion
Sorenson Medical, Inc.
ambIT Ambulatory Infusion Pump Cassette; Filterless, Male, Sterile, Vol. 2.3ml, REF 220267, Sorenson Medical, Inc., West Jordan, Utah.
| Date | Nov 16, 2006 (initiated Oct 10, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Consignees were notified by letter on 10/10-11/2006 and told to immediately discontinue use/quarantine all affected cassettes. . |
| Quantity | 4956 units |
| Distribution | Worldwide, including USA, Belgium, France, Germany, Italy, Singapore, Venezuela. |
| FDA record | Open on fda.gov |