Z-0307-06

Isulin Pump. Model IR1000

Name: Z-0307-06 Isulin Pump. Model IR1000
Creator: Animas Corporation
Published: 2005-10-31
License: https://open.fda.gov/license/

Animas Corp. / initiated 2005-10-31 / Terminated

FDA source

Animas Corporation began a recall of Isulin Pump. Model IR1000 on 2005-10-31. The reason FDA records is "Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0307-06
Status: Terminated
Initiated: 2005-10-31
Posted: 2005-12-23
Terminated: 2005-12-23
Recalling firm: Animas Corp.
Product: Isulin Pump. Model IR1000
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
FDA root cause: Other
Action: The recalling firm telephoned the users on 10/31/05 to inform them of the problem and that the pump would be replaced if the user choose to return it.
Quantity in commerce: 6 units
Distribution: The pumps were shipped to patients CA, CO, FL, IL, KS, MA, MI, NJ, NY, NC, NV, PA,TN, TX, WI, and WV.
Product codes and lots: Model number IR1000

Product code LZG

K021439Class IIModel R1000 Ir Insulin Pump, Ezlink Software, Sermon Software, R1000 Ir Download Cradle, and Serial Interface Adaptor DoAnimas Corp. / cleared 2002-05-29

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)