Isulin Pump. Model IR1000
This recall has been terminated (originally issued December 23, 2005).
- Company
- Animas Corporation
- Recall Initiated
- October 31, 2005
- Posted
- December 23, 2005
- Terminated
- December 23, 2005
- Recall Number
- Z-0307-06
- Quantity
- 6 units
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
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 / Code Info
Model number IR1000
Root Cause
Other
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.
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