Z-0929-05

Animas IR 1250 Insulin Pump

Name: Z-0929-05 Animas IR 1250 Insulin Pump
Creator: Animas Corporation
Published: 2005-04-11
License: https://open.fda.gov/license/

Animas Corp. / initiated 2005-04-11 / Terminated

FDA source

Animas Corporation began a recall of Animas IR 1250 Insulin Pump on 2005-04-11. The reason FDA records is "pump failed to respond to keypad button pressess after using the food database feature". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0929-05
Status: Terminated
Initiated: 2005-04-11
Posted: 2005-06-25
Terminated: 2006-01-24
Recalling firm: Animas Corp.
Product: Animas IR 1250 Insulin Pump.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: pump failed to respond to keypad button pressess after using the food database feature
FDA root cause: Other
Action: The recalling firm issued a recall notice dated 4/11/05 to all patients and healthcare providers via first class mail. The letter instructs the patient to reset the pump, thus correcting any problems caused by the software bug, and to discontinue use of the food database. All distributors were contacted by phone on 4/12/05 and instructed to return all pumps in their inventory. On 4/25/05, the recalling began emailing and telephoning patients to arrange for replacement and return of the devices.
Quantity in commerce: 2081 units
Distribution: The products were shipped to distributors in FL, TX, UT, and VA. The products were also shipped to patients nationwide.
Product codes and lots: Model IR1250

Product code LZG

K042873Class IIAnimas Model Ir1250 Insulin Infusion PumpAnimas Corp. / cleared 2004-12-10

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)