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Disetronic H-Tron Insulin Pump
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FDA Recalls Disetronic H-Tron Insulin Pumps

Oct 8, 2003 | www.fda.gov

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.

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.

DISTRIBUTION: Nationwide.


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