Medex LOGICAL CATH LAB KIT, List Number M20754

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: UDI-DI: 10351688510686; Lot Number: 4371054

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