FDA-Device2014-11-05Class II
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 Corporation
Hazard
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.
Sold states
International Distribution in Israel only.
Affected count
1028
Manufactured in
200 Lawrence Dr, N/A, West Chester, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0136-2015Don't want to check this manually?
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