FDA Medical Device Recalls (openFDA)
Dana Diabecare USA LLC: DANA Diabecare II insulin pumps
- Recall number
- Z-1451-04
- Recalling firm
- Dana Diabecare USA LLC
- Product
- DANA Diabecare II insulin pumps
- Status
- Terminated
- Initiated
- 2004-05-26
- Posted
- 2004-09-14
- Terminated
- 2004-12-10
- Reason
- There is a switch malfunction that that may cause the unit not to respond when command key is depressed.
- Root cause
- Other
- Action
- An email was sent to the sales representatives requesting the return of the pumps. The patients were contacted by telephone and letters requesting the return of the pumps.
- Quantity
- not on file
- Distribution
- AZ, WV, PA, FL, WI, MI, TN, MD
- Lot, serial or model codes
- Serial numbers: AEE001FC ¿ AEE039FC, AEE041FC, AEE043FC ¿ AEE048FC, AEE083FC ¿ AEE132FC
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3003432903
- Firm city
- New Orleans
- Firm state
- LA
- 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