FDAFDA · Food and drugs·Recall number Z-0745-2024
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
Published January 24, 2024 · Recall initiated: November 10, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical Asd Inc
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, UAE.
- Lot
- Lot Number: 4398428 4404690
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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