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.
Enforcement
- Recall Number
- Z-0136-2015
- Event ID
- 69293
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Animas Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 5, 2014
- Initiation Date
- June 10, 2014
- Classification Date
- October 24, 2014
- Termination Date
- September 2, 2015
- Address
- 200 Lawrence Dr, N/A, West Chester, PA, 19380-3428, United States
Description
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.
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.
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
International Distribution in Israel only.
1028