Disetronic H-Trons Insulin Pump. PRODUCT:
a) Disetronic H-TRON V100 Insulin Pump, catalog # 8010030C
(clear case) and 8010030 (solid-color case).
Recall # Z-1196-03;
b) Disetronic H-TRONplus Insulin Pump, catalog # 8050023
(clear case), 8050064 (blue case), 8050021 (solid-
color case) and 8050071 (yellow case).
Recall # Z-1197-0.
CODE: All units.
RECALLING FIRM/MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by letter dated July 16, 2003. FDA initiated recall is ongoing.
Lack of assurance of reliability, due to quality system regulations violations
REASON: Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.
VOLUME OF PRODUCT IN COMMERCE: 2,082.
The authorities found out that the recalled Disetronic H-Trons Insulin Pump product can endanger the lives of many people. This is the main reason why they are being recalled from distribution and selling. Anyone found selling the products after the recall order may face the stricter implementation of the law, according to authorities.