Animas 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.
This recall has been terminated (originally issued October 24, 2014).
- Company
- Animas Corporation
- Recall Initiated
- June 10, 2014
- Posted
- October 24, 2014
- Terminated
- September 2, 2015
- Recall Number
- Z-0136-2015
- Quantity
- 1028
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
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.
Distribution
International Distribution in Israel only.
Lot / Code Info
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
Root Cause
Employee error
Action Taken
A 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.