FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case].
- Recall number
- Z-1197-03
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Disetronic H-TRONplus Insulin Pump; catalog # 8050023 [clear case], 8050064 [blue case], 8050021 [solid-color case] and 8050071 [yellow case].
- Status
- Terminated
- Initiated
- 2003-07-21
- Posted
- 2003-09-17
- Terminated
- 2009-03-10
- Reason
- Lack of assurance of reliability, due to quality system regulations violations, plus notice to users not to expose pump to water.
- Root cause
- Other
- Action
- An urgent product correction and removal letter dated 7/16/03 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
- not on file
- Distribution
- United States
- Lot, serial or model codes
- All units.
- 510(k) numbers
- ["K023471"]
- 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