Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.
Hazard
The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.
What You Should Do
Remedy
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.
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Products
Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.
- Brand
- Roche Diagnostics Corp.
- UPC
- 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.
Units Affected
107 pediatric patients use the device.