FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.
- Recall number
- Z-1105-05
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Disetronic D-Tronplus Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in packages of ten adapters.
- Status
- Terminated
- Initiated
- 2005-07-15
- Posted
- 2005-08-06
- Terminated
- 2006-02-07
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K043000"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28