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Terminated

DANA Diabecare II insulin pumps

FDA Recall Z-1451-04 · Posted 2004-09-14

Recalling FirmDana Diabecare USA LLC
Recall StatusTerminated
Product CodeLZG
Date Initiated2004-05-26
Date Terminated2004-12-10

Reason for Recall

There is a switch malfunction that that may cause the unit not to respond when command key is depressed.

Firm Action

An email was sent to the sales representatives requesting the return of the pumps. The patients were contacted by telephone and letters requesting the return of the pumps.

Root Cause

Other

Distribution Pattern

AZ, WV, PA, FL, WI, MI, TN, MD

Official Source

View FDA Recall →

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

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