FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Disetronic D-TRONplus Insulin Pump
- Recall number
- Z-1198-03
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Disetronic D-TRONplus Insulin Pump
- Status
- Terminated
- Initiated
- 2003-07-24
- Posted
- 2003-09-23
- Terminated
- 2009-03-10
- Reason
- Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.
- Root cause
- Other
- Action
- An urgent product correction and removal letter dated 7/24/03 was issued to each pump user informing of potential problems with the pump and instructing them how to proceed if they wish to discontinue use of the pump, have it replaced, or have questions regarding the pump.
- Quantity
- 8000
- Distribution
- United States
- Lot, serial or model codes
- all units.
- 510(k) numbers
- K022831
- 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