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U.S. Department of Health and Human Services

Class 2 Device Recall Animas Vibe Insulin Infusion Pump and System

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 Class 2 Device Recall Animas Vibe Insulin Infusion Pump and Systemsee related information
Date Initiated by FirmOctober 25, 2012
Date PostedOctober 24, 2014
Recall Status1 Terminated 3 on June 29, 2015
Recall NumberZ-0137-2015
Recall Event ID 69296
Product Classification Pump, infusion, insulin - Product Code LZG
ProductAnimas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Code Information Part Numbers  101200-57 100512-57 100510-02  100510-03  100510-04 100510-53 100510-56 100510-57 100510-63 100510-67 100511-02 100511-03 100511-04 100511-53 100511-56 100511-57 100511-63 100512-02 100512-02 100512-03 100512-04 100512-53 100512-56 100512-57 100512-63 100514-02 100514-03 100514-04 100514-53 100514-56 100514-57 100514-63 100515-02 100515-03 100515-04 100515-53 100515-56 100515-57 100515-63 101200-02 101002-03 101002-53 101002-56 101002-57 101002-63 101201-02 101201-03 101201-53  101210-56 101201-57 101201-63 101202-02 101202-03 101202-04 101202-53 101202-57 101202-63 101204-03 101204-04 101204-53 101204-57 101204-63 101205-03 101205-53 101205-56 101205-57 101205-63      
Recalling Firm/
Manufacturer		 Animas Corporation
200 Lawrence Dr
West Chester PA 19380-3428
For Additional Information ContactCustomer Support
610-644-8900
Manufacturer Reason
for Recall		Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump and System. Animas has implemented an improvement to the keypad related to the material used to reduce susceptibility to damage and increase durability.
FDA Determined
Cause 2		Device Design
ActionAnimas initiated the notification to Distributors by letter, dated July 2012, and Patients and Health Care Professionals were notified by letter in September 2012. The delay in notifying patients and health care professionals was driven by the need to have sufficient inventory of replacement product on hand in order to meet anticipated demand before sending the letters.
Quantity in Commerce1938
DistributionWorldwide Distribution in the countries of France, Italy, Sweden, and UK..
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.
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