Roche Diagnostics Corp. Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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.
Roche Diagnostics Corp. is recalling Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold i due to The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026