IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.
FDA device recall Z-0211-05 · posted 2004-11-19 · Terminated
Recall details
- Recalling firm
- Animas Corporation
- Reason for recall
- Suspend mode not functioning properly
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 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,
- Date initiated
- 2004-09-28
- Date posted
- 2004-11-19
- Date terminated
- 2005-03-10
- Location
- West Chester, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL IR 1200 INSULIN PUMP (K032257) | Animas Corp. | 2003-10-16 |