Recall Z-1105-05 ยท LZG Pump, Infusion, Insulin
Roche Diagnostics Corp.
Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.
| Date | Aug 6, 2005 (initiated Jul 15, 2005) |
| Status | Terminated |
| Reason | 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 | 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 | 107 pediatric patients use the device. |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043000 | MODIFICATION TO D-TRONPLUS Disetronic Medical Systems AG, Dec 1, 2004 |