Z-0747-2024 Class II Ongoing
FDA device recall Z-0747-2024 was initiated by Smiths Medical Asd Inc on November 10, 2023 and is designated Class II. 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 lea… The recall status is ongoing. Affected quantity: 31,685 total.
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
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
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
Lot Number: 4383431 4387987 4404698