FDA-Device2024-12-04Class II
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
Sold states
US Nationwide distribution in the state of NY.
Affected count
100
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0558-2025Don't want to check this manually?
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