FDA-Device2023-12-20Class II
PVP SOLUTION SING STRL, REF DYNDA1858
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
1950 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
PVP SOLUTION SING STRL, REF DYNDA1858
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0529-2024Don't want to check this manually?
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