FDA Medical Device Recalls (openFDA)
Disetronic Medical Systems, Inc.: Accu-Chek Ultraflex-1 infusion set; 10 mm (30 cm); (Distributed outside the US only).
- Recall number
- Z-1137-06
- Recalling firm
- Disetronic Medical Systems, Inc.
- Product
- Accu-Chek Ultraflex-1 infusion set; 10 mm (30 cm); (Distributed outside the US only).
- Status
- Terminated
- Initiated
- 2006-03-31
- Posted
- 2006-07-08
- Terminated
- 2007-11-06
- Reason
- The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia
- Root cause
- Other
- Action
- "U.S. and International distributors, patients and their physicians were notified via letters dated 3/31/06. Distributors were instructed to search for all part numbers affected by the recall and to provide all affected customers and sub-distributors with the recall notice. Customers were offered a replacement set or replacement with a different model. A press release was also issued on 4/3/06.
- Quantity
- 3,070 outside North America
- Distribution
- Worldwide including USA, Argentina, Austria, Barbados, Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Honduras, Hungary, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
- Lot, serial or model codes
- Lots 4E139UF, 4F198UF and 4H155UF.
- 510(k) numbers
- not on file
- 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