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U.S. Department of Health and Human Services

Class 1 Device Recall AccuChek

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  Class 1 Device Recall AccuChek see related information
Date Initiated by Firm March 31, 2006
Date Posted July 08, 2006
Recall Status1 Terminated 3 on November 06, 2007
Recall Number Z-1127-06
Recall Event ID 34905
510(K)Number K033892  
Product Classification Infusion set - Product Code LZG
Product Accu-Chek Ultraflex-2 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540972001.
Code Information Lots 5C138UF, 5D048UF, 5E104UF, 5E152UF, 5F049UF, 5G017UF, 5I007UF, 5J063UF and 5J094UF.
Recalling Firm/
Disetronic Medical Systems, Inc.
11800 Exit 5 Parkway, Suite 120
Fishers IN 46038
For Additional Information Contact
Manufacturer 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 Determined
Cause 2
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 28,890 in US and Canada
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = DISETRONIC MEDICAL SYSTEMS AG