FDA Medical Device Recalls (openFDA)
Animas Corporation: IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.
- Recall number
- Z-0211-05
- Recalling firm
- Animas Corporation
- Product
- IR 1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C.
- Status
- Terminated
- Initiated
- 2004-09-28
- Posted
- 2004-11-19
- Terminated
- 2005-03-10
- Reason
- Suspend mode not functioning properly
- 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
- 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.
- Lot, serial or model codes
- Model IR 1200
- 510(k) numbers
- ["K032257"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3002920072
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28