Accu-Chek Ultraflex-1 infusion set; 8 mm (30 cm); (Distributed outside the US only).

FDA device recall Z-1136-06 · posted 2006-07-08 · Terminated

Recall details

Recalling firm

Disetronic Medical Systems, Inc.

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

Action taken

"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.

Root cause

Other

Status

Terminated

Product code

LZG

Quantity affected

7,390 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,

Date initiated

2006-03-31

Date posted

2006-07-08

Date terminated

2007-11-06

Location

Fishers, IN