There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.
Reason for recall: There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach. Distribution: US Nationwide distribution in the states of MN, NJ, TN. Quantity: 37 units Lot/code info: UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590
00813502013252
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.