FDA-Device2023-09-20Class I

HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U

Hazard

Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.

Sold states
US Nationwide distribution.
Affected count
18,000 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2514-2023

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