Z-1188-06

ambIT Ambulatory Infusion Therapy Intermittent Pump

Name: Z-1188-06 ambIT Ambulatory Infusion Therapy Intermittent Pump
Creator: Sorenson Medical, Inc.
Published: 2006-05-03
License: https://open.fda.gov/license/

Sorenson Medical, Inc. / initiated 2006-05-03 / Terminated

FDA source

Sorenson Medical, Inc. began a recall of ambIT Ambulatory Infusion Therapy Intermittent Pump on 2006-05-03. The reason FDA records is "Intermittent Infusion pump may continually dispense medication under certain conditions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1188-06
Status: Terminated
Initiated: 2006-05-03
Posted: 2006-07-01
Terminated: 2006-08-09
Recalling firm: Sorenson Medical, Inc.
Product: ambIT Ambulatory Infusion Therapy Intermittent Pump
Product code: FRN Pump, Infusion
Reason for recall: Intermittent Infusion pump may continually dispense medication under certain conditions.
FDA root cause: Other
Action: All direct accounts were contacted by email and phone on 05/03/2006. Distributors were instructed to identify end users for Recalling Firm notification
Quantity in commerce: 72 pumps
Distribution: Worldwide distribution (including-states of IL, KS, NJ, PA, WA. , countries of Germany, Malaysia, New Zealand, Slovenia.
Product codes and lots: Catalog Number: 220245. All serial numbers.

Product code FRN

K033425Class IIAmbit Intermittent Ambulatory Infusion PumpSorenson Medical, Inc. / cleared 2003-11-06

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)