Recall Z-1196-03 ยท LZG Pump, Infusion, Insulin
Roche Diagnostics Corp.
Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-color case]
| Date | Sep 17, 2003 (initiated Jul 21, 2003) |
| Status | Terminated |
| Reason | Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water. |
| Root cause | Other |
| Action | 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. |
| Distribution | United States |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905693 | H-TRON V 100 INSULIN INFUSION PUMP Disetronic Medical Systems, Apr 12, 1991 |