Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten ad
FDA device recall Z-1105-05 · posted 2005-08-06 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZG
- Quantity affected
- 107 pediatric patients use the device.
- Distribution
- Nationwide.
- Date initiated
- 2005-07-15
- Date posted
- 2005-08-06
- Date terminated
- 2006-02-07
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO D-TRONPLUS (K043000) | Disetronic Medical Systems AG | 2004-12-01 |