Z-1244-03

Disetronic Dahedi insulin infusion pump; catalog # 8500019

Name: Z-1244-03 Disetronic Dahedi insulin infusion pump; catalog # 8500019
Creator: Roche Diagnostics Corp.
Published: 2003-07-28
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2003-07-28 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Disetronic Dahedi insulin infusion pump; catalog # 8500019 on 2003-07-28. The reason FDA records is "Lack of assurance of reliability". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1244-03
Status: Terminated
Initiated: 2003-07-28
Posted: 2003-09-23
Terminated: 2007-01-12
Recalling firm: Roche Diagnostics GmbH
Product: Disetronic Dahedi insulin infusion pump; catalog # 8500019.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Lack of assurance of reliability.
FDA root cause: Other
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.
Quantity in commerce: 508
Distribution: United States.
Product codes and lots: All units

Product code LZG

K991376Class IIDahedi Insulin Infusion PumpDisetronic Medical Systems / cleared 1999-06-15

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)