Disetronic D-TRONplus Insulin Pump
This recall has been terminated (originally issued September 23, 2003).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- July 24, 2003
- Posted
- September 23, 2003
- Terminated
- March 10, 2009
- Recall Number
- Z-1198-03
- Quantity
- 8000
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.
Distribution
United States
Lot / Code Info
all units.
Root Cause
Other
Action Taken
An urgent product correction and removal letter dated 7/24/03 was issued to each pump user informing of potential problems with the pump and instructing them how to proceed if they wish to discontinue use of the pump, have it replaced, or have questions regarding the pump.
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