Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-color case]
This recall has been terminated (originally issued September 17, 2003).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- July 21, 2003
- Posted
- September 17, 2003
- Terminated
- March 10, 2009
- Recall Number
- Z-1196-03
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.
Distribution
United States
Lot / Code Info
All units.
Root Cause
Other
Action Taken
An urgent product correction and removal letter dated 7/16/03 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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