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U.S. Department of Health and Human Services

Class 2 Device Recall DANA Diabecare II insulin pumps

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  Class 2 Device Recall DANA Diabecare II insulin pumps see related information
Date Initiated by Firm May 26, 2004
Date Posted September 14, 2004
Recall Status1 Terminated 3 on December 10, 2004
Recall Number Z-1451-04
Recall Event ID 29472
Product Classification Pump, Infusion, Insulin - Product Code LZG
Product DANA Diabecare II insulin pumps
Code Information Serial numbers: AEE001FC ¿ AEE039FC, AEE041FC, AEE043FC ¿ AEE048FC, AEE083FC ¿ AEE132FC
Recalling Firm/
Manufacturer
Dana Diabecare USA LLC
541 Julia Street, 3rd Floor
New Orleans LA 70130
Manufacturer Reason
for Recall
There is a switch malfunction that that may cause the unit not to respond when command key is depressed.
FDA Determined
Cause 2
Other
Action An email was sent to the sales representatives requesting the return of the pumps. The patients were contacted by telephone and letters requesting the return of the pumps.
Distribution AZ, WV, PA, FL, WI, MI, TN, MD
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.
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