Z-0186-2007

ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Sorenson Medical...

Name: Z-0186-2007 ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Sorenson Medical...
Creator: Sorenson Medical, Inc.
Published: 2006-10-10
License: https://open.fda.gov/license/

Sorenson Medical, Inc. / initiated 2006-10-10 / Terminated / root cause: sterility

FDA source

Sorenson Medical, Inc. began a recall of ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Sorenson Medical, Inc., West Jordan, Utah on 2006-10-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0186-2007
Status: Terminated
Initiated: 2006-10-10
Posted: 2006-11-16
Terminated: 2011-05-26
Recalling firm: Sorenson Medical, Inc.
Product: ambIT Ambulatory Infusion Pump Cassette; Filter, Spike, Sterile, Vol. 2.3ml, REF 220140, Sorenson Medical, Inc., West Jordan, Utah.
Product code: FRN Pump, Infusion
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.
Root cause tag: sterility
FDA 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 in commerce: 30,697 units
Distribution: Worldwide, including USA, Belgium, France, Germany, Italy, Singapore, Venezuela.
Product codes and lots: REF 220140, all serial numbers

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)