FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Disetronic Dahedi insulin infusion pump; catalog # 8500019.
- Recall number
- Z-1244-03
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Disetronic Dahedi insulin infusion pump; catalog # 8500019.
- Status
- Terminated
- Initiated
- 2003-07-28
- Posted
- 2003-09-23
- Terminated
- 2007-01-12
- Reason
- Lack of assurance of reliability.
- Root cause
- Other
- Action
- A recall letter dated 8/5/03 was issued to each user instructing them that they will receive a new pump and, upon receipt of the new pump, they will be required to return their Dahedi pump to the firm's representative.
- Quantity
- 508
- Distribution
- United States.
- Lot, serial or model codes
- All units
- 510(k) numbers
- ["K991376"]
- 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