FDA recall Z-2514-2023

MEDLINE INDUSTRIES, LP - Northfield · Class I · device

Product

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-08-04
Report date
2023-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

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