PlainRecalls
FDA Devices Critical Class I Ongoing

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

Reported: September 20, 2023 Initiated: August 4, 2023 #Z-2514-2023

Product Description

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

Reason for Recall

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

Details

Units Affected
18,000 units
Distribution
US Nationwide distribution.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 18,000 units.
Why was this product recalled?
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 20, 2023. Severity: Critical. Recall number: Z-2514-2023.