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Terminated

Disetronic Dahedi insulin infusion pump; catalog # 8500019.

FDA Recall Z-1244-03 · Posted 2003-09-23

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLZG
Date Initiated2003-07-28
Date Terminated2007-01-12
Product Quantity508

Reason for Recall

Lack of assurance of reliability.

Firm Action

A recall letter dated 8/5/03 was issued to each user instructing them that they will receive a new pump and, upon receipt of the new pump, they will be required to return their Dahedi pump to the firm's representative.

Root Cause

Other

Distribution Pattern

United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991376DAHEDI INSULIN INFUSION PUMPDisetronic Medical Systems · 1999-06-15

Official Source

View FDA Recall →

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

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