Z-1197-03

Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color...

Name: Z-1197-03 Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color...
Creator: Roche Diagnostics Corp.
Published: 2003-07-21
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2003-07-21 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case] on 2003-07-21. The reason FDA records is "Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1197-03
Status: Terminated
Initiated: 2003-07-21
Posted: 2003-09-17
Terminated: 2009-03-10
Recalling firm: Roche Diagnostics GmbH
Product: Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case].
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.
FDA root cause: Other
Action: An urgent product correction and removal letter dated 7/16/03 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.
Distribution: United States
Product codes and lots: All units.

Product code LZG

K023471Class IIDisetronic H-Tronplus Insulin Infusion PumpDisetronic Medical Systems AG / cleared 2002-10-29

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)