Z-1117-06

Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and...

Name: Z-1117-06 Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and...
Creator: Disetronic Medical Systems, Inc.
Published: 2006-03-31
License: https://open.fda.gov/license/

Disetronic Medical Systems / initiated 2006-03-31 / Terminated

FDA source

Disetronic Medical Systems, Inc. began a recall of Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and Canada) and Ref No. 04626478001 (Distributed... on 2006-03-31. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1117-06
Status: Terminated
Initiated: 2006-03-31
Posted: 2006-07-08
Terminated: 2007-11-06
Recalling firm: Disetronic Medical Systems
Product: Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and Canada) and Ref No. 04626478001 (Distributed outside the U.S. only).
Product code: LZG Pump, Infusion, Insulin
Reason for recall: 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
FDA 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 in commerce: 564,310 in US and Canada plus 11,800 outside N. 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.
Product codes and lots: Lots 2J081UF, 2J066UF, 2K032UF, 2K050UF, 2K057UF, 2L009UF, 2L079UF, 3A002UF, 3A028UF, 3B011UF, 3C047UF, 3D139UF, 3F074UF, 3F084UF, 3F117UF, 3G025UF, 3G039UF, 3G064UF, 3G084UF, 3G151UF, 3H026UF, 3H034UF, 3H058UF, 3I117UF, 3J048UF, 3K001UF, 3K084UF, 3L079UF, 4A107UF, 4A116UF, 4C133UF, 4C153UF, 4C156UF, 4D133UF, 4E118UF, 4F005UF, 4F135UF, 4F180UF, 4G159UF, 4H066UF, 4H149UF, 4I048UF, 4J004UF, 4J148UF, 4K065UF, 4L079UF, 5B005UF, 5C191UF, 5E070UF, 5F148UF, 5G187UF, 5I092UF, 5I204UF, 5J195UF, 5K027UF, 5L005UF and 6B078UF..

Product code LZG

K033892Class IIUltraflex Infusion SetDisetronic Medical Systems AG / cleared 2004-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)