FDA-Device2023-09-20Class I

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

MEDLINE INDUSTRIES, LP - Northfield
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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