Z-0211-05

IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C

Name: Z-0211-05 IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C
Creator: Animas Corporation
Published: 2004-09-28
License: https://open.fda.gov/license/

Animas Corp. / initiated 2004-09-28 / Terminated

FDA source

Animas Corporation began a recall of IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C on 2004-09-28. The reason FDA records is "Suspend mode not functioning properly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0211-05
Status: Terminated
Initiated: 2004-09-28
Posted: 2004-11-19
Terminated: 2005-03-10
Recalling firm: Animas Corp.
Product: IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Suspend mode not functioning properly
FDA root cause: Other
Action: The recalling firm issued a notice entitled 'Important Safety Information Regarding the Animas IR 1200 Pump' dated 9/28/04 to the health care professionals and distributors. The letter informed the reader of the problem and to use an alternate feature. Health care professionals should notify patients of the problem.
Quantity in commerce: 7395 units
Distribution: The products are shipped to diabetic supply companies in FK, NE, NV, NJ, NY, OH, OK, TX, VA, and WA then further shipped to patients nationwide. The products were shipped to government accounts in IL, MD, and SC. The product was also shipped to a supply company in Israel.
Product codes and lots: Model IR 1200

Product code LZG

K032257Class IIModel Ir 1200 Insulin PumpAnimas Corp. / cleared 2003-10-16

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)