Animas Corporation IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.
Brand
Animas Corporation
Lot Codes / Batch Numbers
Model IR 1200
Products Sold
Model IR 1200
Animas Corporation is recalling IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C. due to Suspend mode not functioning properly. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Suspend mode not functioning properly
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026