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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 AccuCheksee related information
Date Initiated by FirmMarch 31, 2006
Date PostedJuly 08, 2006
Recall Status1 Terminated 3 on November 06, 2007
Recall NumberZ-1122-06
Recall Event ID 34905
510(K)NumberK033892 
Product Classification Infusion set - Product Code LZG
ProductAccu-Chek Ultraflex-2 infusion set; 8 mm 24'' (60 cm); Catalog number INF 04540921001.
Code Information Lots 5B026UF, 5C058UF, 5D177UF, 5E087UF, 5F099UF, 5I028UF, 5J104UF, 5J130UF, 6B112UF and 6B118UF.
Recalling Firm/
Manufacturer		 Disetronic Medical Systems, Inc.
11800 Exit 5 Parkway, Suite 120
Fishers IN 46038
For Additional Information Contact
800-688-4578
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		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 Commerce56,600 in US and Canada
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = LZG
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