FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25 cartridges, 25 needles; manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 300.0419.
- Recall number
- Z-1223-04
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Disetronic brand 3.15 ml glass cartridges used with H-tron, H-tron plus, Panomat C, Panomat P, Panomat T, Panomat V and Dahedi Infusion pumps and Pen 10 insulin pens in box of 25 cartridges, 25 needles; manufactured by Disetronic Medical Systems AG, CH-3401, Burgdorf, Switzerland; catalog number 300.0419.
- Status
- Terminated
- Initiated
- 2004-05-17
- Posted
- 2004-07-20
- Terminated
- 2006-05-10
- Reason
- Lack of assurance of sterility.
- Root cause
- Other
- Action
- The firm issued recall letters dated 5/17/04 to all users. A dear doctor letter issued to prescribers instructing them to discontinue prescription of the glass cartridges.
- Quantity
- not on file
- Distribution
- Worldwide.
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- ["K973044"]
- 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