Z-1451-04

DANA Diabecare II insulin pumps

Name: Z-1451-04 DANA Diabecare II insulin pumps
Creator: Dana Diabecare USA LLC
Published: 2004-05-26
License: https://open.fda.gov/license/

Dana Diabecare USA LLC / initiated 2004-05-26 / Terminated

FDA source

Dana Diabecare USA LLC began a recall of DANA Diabecare II insulin pumps on 2004-05-26. The reason FDA records is "There is a switch malfunction that that may cause the unit not to respond when command key is depressed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1451-04
Status: Terminated
Initiated: 2004-05-26
Posted: 2004-09-14
Terminated: 2004-12-10
Recalling firm: Dana Diabecare USA LLC
Product: DANA Diabecare II insulin pumps
Product code: LZG Pump, Infusion, Insulin
Reason for recall: There is a switch malfunction that that may cause the unit not to respond when command key is depressed.
FDA root cause: Other
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.
Distribution: AZ, WV, PA, FL, WI, MI, TN, MD
Product codes and lots: Serial numbers: AEE001FC ¿ AEE039FC, AEE041FC, AEE043FC ¿ AEE048FC, AEE083FC ¿ AEE132FC

Product code LZG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)