FDA-Device2015-02-11Class 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
Calibration factors in the pump overwritten during a programming step. The force sensor could send a lower signal value to the pump processor, with loss of prime warnings, occlusion alarms and the pump unable to detect a cartridge during the prime sequence. Field action initiated 8/29/2011.
Sold states
No US distribution, Distributors are located in France, Germany, Sweden and United Kingdom.
Affected count
1235
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-1034-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief