48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R

Reason: 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.

Code information: Lot Number: 4383431 4387987 4404698

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, UAE.