FDA-Device2025-04-02Class II
Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
90 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1453-2025Don't want to check this manually?
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