There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Reason for recall: There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE. Quantity: 31,685 total Lot/code info: Lot Number: 4387166
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.