FDA-Drug2018-02-07Class II

Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates., Tahlequah, OK 74464

Medline Industries Inc
Hazard

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

Sold states
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Affected count
5,400 cases
Manufactured in
Three Lakes Drive, Northfield, IL, United States
Products
Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates., Tahlequah, OK 74464

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0299-2018

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