Z-2514-2023 Class I Ongoing
FDA device recall Z-2514-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on August 4, 2023 and is designated Class I. Reason for recall: Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers. The recall status is ongoing. Affected quantity: 18,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2023
- Initiation Date
- August 4, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,000 units
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI/DI 140267047147818, Lot code 3B085