FDA Device

Disetronic D-TRONplus Insulin Pump

Hazard

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.

What You Should Do

Remedy

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.

Products

Disetronic D-TRONplus Insulin Pump
Brand
Roche Diagnostics Corp.
UPC
all units.

Units Affected

8000