Device product
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Z-2514-2023
Product summary
- Event
- Event 92834
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 18,000 units
- Official record key
device-enforcement:Z-2514-2023
Official wording
Reason: Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
Code information: UDI/DI 140267047147818, Lot code 3B085
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.