Recall Z-1198-03 ยท LZG Pump, Infusion, Insulin
Roche Diagnostics Corp.
Disetronic D-TRONplus Insulin Pump
| Date | Sep 23, 2003 (initiated Jul 24, 2003) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 8000 |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022831 | MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP Disetronic Medical Systems AG, Sep 11, 2002 |