FDA-Device2023-12-20Class II
STERILE PVP SLN KIT, REF DYNDM1097
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
100 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
STERILE PVP SLN KIT, REF DYNDM1097
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0526-2024Don't want to check this manually?
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