FDA Enforcement
Class II
Ongoing
Medex LOGICAL CATH LAB KIT, List Number M20754
Recall: Z-0739-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0739-2024
- Event ID
- 93506
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Smiths Medical Asd Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 24, 2024
- Initiation Date
- November 10, 2023
- Classification Date
- January 17, 2024
- Address
- 6250 Shier Rings Rd, N/A, Dublin, OH, 43016-1270, United States
Description
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 Info
UDI-DI: 10351688510686; Lot Number: 4371054
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, UAE.
Quantity
31,685 total