Z-0739-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- November 10, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,685 total
Product Description
Medex LOGICAL CATH LAB KIT, List Number M20754
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 Pattern
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
Code Information
UDI-DI: 10351688510686; Lot Number: 4371054