| Class 1 Device Recall AccuChek |  |
Date Initiated by Firm | March 31, 2006 |
Date Posted | July 08, 2006 |
Recall Status1 |
Terminated 3 on November 06, 2007 |
Recall Number | Z-1119-06 |
Recall Event ID |
34905 |
510(K)Number | K033892 |
Product Classification |
Pump, Infusion, Insulin - Product Code LZG
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Product | Accu-Chek Ultraflex-1 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540867001. |
Code Information |
Lots 31026UF, 31058UF, 3C122UF, 3D039UF, 3D050UF, 3E039UF, 3G045UF, 3G122UF, 3I135UF, 3J024UF, 3J059UF, 3J154UF, 3K043UF, 3K119UF, 3L134UF, 4B021UF, 4D006UF, 4D191UF, 4E126UF, 4F026UF, 4G037UF, 4H006UF, 4H036UF, 4H134UF, 4H205UF, 4I192UF, 4J020UF, 4J172UF, 4K107UF, 5A195UF, 5D004UF, 5D234UF, 5F089UF, 5G178UF, 5I049UF, 5I101UF, 5J157UF, 5K014UF, 5K058UF, 5K078UF and 6B095UF. |
Recalling Firm/ Manufacturer |
Disetronic Medical Systems, Inc. 11800 Exit 5 Parkway, Suite 120 Fishers IN 46038
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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 Commerce | 251,480 in US and Canada plus 17,450 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. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LZG
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