IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.
This recall has been terminated (originally issued November 19, 2004).
- Company
- Animas Corporation
- Recall Initiated
- September 28, 2004
- Posted
- November 19, 2004
- Terminated
- March 10, 2005
- Recall Number
- Z-0211-05
- Quantity
- 7395 units
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Suspend mode not functioning properly
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.
Lot / Code Info
Model IR 1200
Root Cause
Other
Action Taken
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.
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