FDA-Device2024-09-04Class II
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) CIRCUMCISION TRAY, Pack Number CIT6720; 3) CIRCUMCISION TRAY, Pack Number CIT6720A
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.
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) CIRCUMCISION TRAY, Pack Number CIT6720; 3) CIRCUMCISION TRAY, Pack Number CIT6720A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2779-2024Don't want to check this manually?
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