FDA-Device2023-12-20Class II

STERILE POVIDONE, REF DYNDA2061

MEDLINE INDUSTRIES, LP - Northfield
Hazard

The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

Sold states
US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
Affected count
300 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
STERILE POVIDONE, REF DYNDA2061

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0531-2024

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