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Terminated

Disetronic H-TRON V100 Insulin Pump; catalog # 8010030C [clear case] and 8010030 [solid-color case]

FDA Recall Z-1196-03 · Posted 2003-09-17

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLZG
Date Initiated2003-07-21
Date Terminated2009-03-10

Reason for Recall

Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.

Firm 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.

Root Cause

Other

Distribution Pattern

United States

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K905693H-TRON V 100 INSULIN INFUSION PUMPDisetronic Medical Systems · 1991-04-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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