FDA
Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8.
Potential for under-infusion without alarm; cassette rollers stop moving , but the pump shaft continues rotating without alarm.
Distributors were notified via letter dated 3/29/05 instructing them to retrieve and return the product.