FDA-Device2025-05-07Class II
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
MEDLINE INDUSTRIES, LP - Northfield
Hazard
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Sold states
Worldwide distribution - US Nationwide and the countries of Panama and Canada.
Affected count
30 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1713-2025Don't want to check this manually?
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