Recall Z-1197-03 ยท LZG Pump, Infusion, Insulin
Roche Diagnostics Corp.
Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow 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
| K023471 | DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP Disetronic Medical Systems AG, Oct 29, 2002 |