Isulin Pump. Model IR1000
FDA device recall Z-0307-06 · posted 2005-12-23 · Terminated
Recall details
- Recalling firm
- Animas Corporation
- Reason for recall
- Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 6 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.
- Date initiated
- 2005-10-31
- Date posted
- 2005-12-23
- Date terminated
- 2005-12-23
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO (K021439) | Animas Corp. | 2002-05-29 |