FDA-Device2023-12-20Class II

STERILE STERILE PREP STICK, REF DYNDA1134

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
240 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
STERILE STERILE PREP STICK, REF DYNDA1134

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0527-2024

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