—#40500

Product

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

FDA product code: LZG — Pump, Infusion, Insulin
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K043000
Affected lot / code info: 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.

Why it was recalled

The adapter valve may not operate correctly, which may result in overdelivery of insulin in the first dose after the adapter has been changed.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2005-07-15
Posted by FDA: 2005-08-06
Terminated: 2006-02-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40500. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.