FDA Medical Device Recalls (openFDA)
Animas Corporation: Isulin Pump. Model IR1250
- Recall number
- Z-0309-06
- Recalling firm
- Animas Corporation
- Product
- Isulin Pump. Model IR1250
- Status
- Terminated
- Initiated
- 2005-10-31
- Posted
- 2005-12-23
- Terminated
- 2005-12-23
- Reason
- Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
- Root cause
- Other
- Action
- The recalling firm telephoned the users on 10/31/05 to inform them of the problem and that the pump would be replaced if the user choose to return it.
- Quantity
- 2 units
- Distribution
- The pumps were shipped to patients CA, CO, FL, IL, KS, MA, MI, NJ, NY, NC, NV, PA,TN, TX, WI, and WV.
- Lot, serial or model codes
- Model number IR1250
- 510(k) numbers
- ["K042873"]
- 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