FDA Medical Device Recalls (openFDA)
Disetronic Medical Systems, Inc.: Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001.
- Recall number
- Z-1413-06
- Recalling firm
- Disetronic Medical Systems, Inc.
- Product
- Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001.
- Status
- Terminated
- Initiated
- 2006-07-13
- Posted
- 2006-09-12
- Terminated
- 2007-11-05
- Reason
- The battery may turn the pump off without warning due to a design change in the battery.
- Root cause
- Other
- Action
- Press release was issued on 7/13/06. Consignees, distributors and health care providers were issued a recall notice dated 7/13/06 instructing replacement of the power pack every two weeks until further notice.
- Quantity
- 6,604 packs to U.S. and Canada.
- Distribution
- Nationwide and Canada.
- Lot, serial or model codes
- Lots 06010107, 06030242, 06040085, 06050110 and 06060126.
- 510(k) numbers
- ["K043000"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 1000116163
- Firm city
- Fishers
- 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