FDA-Device2023-12-20Class II

STERILE PVP, REF DYNDA1649

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
700 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
STERILE PVP, REF DYNDA1649

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0528-2024

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