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Terminated

Disetronic D-TRONplus Insulin Pump

FDA Recall Z-1198-03 · Posted 2003-09-23

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLZG
Date Initiated2003-07-24
Date Terminated2009-03-10
Product Quantity8000

Reason for Recall

Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.

Firm Action

An urgent product correction and removal letter dated 7/24/03 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.

K022831MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMPDisetronic Medical Systems AG · 2002-09-11

Official Source

View FDA Recall →

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

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