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U.S. Department of Health and Human Services

Class 2 Device Recall Animas Vibe Insulin Infusion Pump

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 Class 2 Device Recall Animas Vibe Insulin Infusion Pumpsee related information
Date Initiated by FirmJune 10, 2014
Date PostedOctober 24, 2014
Recall Status1 Terminated 3 on September 02, 2015
Recall NumberZ-0136-2015
Recall Event ID 69293
Product Classification unknown device name - Product Code N/A
ProductAnimas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
Code Information Model Number(s): 11220008 PMPW/OKIT,VIBE,BLU,mg,IL 11220108 PMPW/OKIT,VIBE,BLK,mg,IL 11220208 PMPW/OKIT,VIBE,SIL,mg,IL 11220408 PMPW/OKIT,VIBE,PGL,mg,IL 11220508 PMPW/OKIT,VIBE,LGN,mg,IL 11251008 REV KIT,VIBE,BLU,mg,IL 11251108 REV KIT,VIBE,BLK,mg,IL 11251208 REV KIT,VIBE,SIL,mg,IL 11251408 REV KIT,VIBE,PGL,mg,IL 11251508 REV KIT,VIBE,LGN,mg,IL 11451008 REV KIT,VIBEPL,BLU,mg,IL 11451108 REV KIT,VIBEPL,BLK,mg,IL 11451208 REV KIT,VIBEPL,SIL,mg,IL 11451408 REV KIT,VIBEPL,PGL,mg, IL 11451508 REV KIT,VIBEPL,LGN,mg,IL 11420008 PMPW/OKIT,VIBEPL,BLU,mg,IL 11420108 PMPW/OKIT,VIBEPL,BLK,mg,IL 11420208 PMPW/OKIT,VIBEPL,SIL,mg,IL 11420408 PMPW/OKIT,VIBEPL,PGL,mg,IL 11420508 PMPW/OKIT,VIBEPL,LGN,mg,IL
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 the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted from the display screen.
FDA Determined
Cause 2		Employee error
ActionA recall notification letter, dated June 2014, was sent to the recalling firm's sole customer, TriTech Biomed, in Israel, to notify them about the product, problem, and action to be taken. The distributor sent letters to their customers on July 16, 2014.
Quantity in Commerce1028
DistributionInternational Distribution in Israel only.
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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