Z-1105-05

Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in...

Name: Z-1105-05 Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in...
Creator: Roche Diagnostics Corp.
Published: 2005-07-15
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2005-07-15 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters on 2005-07-15. The reason FDA records is "The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1105-05
Status: Terminated
Initiated: 2005-07-15
Posted: 2005-08-06
Terminated: 2006-02-07
Recalling firm: Roche Diagnostics GmbH
Product: Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.
FDA root cause: Other
Action: The firm began notifying family members of pediatric patients via phone on 7/15/05 and immediately began shipping a recall letter and 10 packs of replacement adapters to each pediatric user. Attending physicians were for these pediatric patients were notified the week of 7/18/05 via phone and follow-up letters were sent to these physicians. The firm is issuing a press release on 7/28/05. Only these replacement adapters are being sold by Disetronic to users of any age ordering new adapters.
Quantity in commerce: 107 pediatric patients use the device.
Distribution: Nationwide.
Product codes and lots: All units with the following lot numbers being used by patients 13 years of age or younger: lots 4013674 through 4022628. The last affected lot expires in April 2007.

Product code LZG

K043000Class IIModification to D-TronplusDisetronic Medical Systems AG / cleared 2004-12-01

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)