HUDSON RCI Addipak recall: Sterility Concern
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Why was HUDSON RCI Addipak recalled?
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 140267047147818, Lot code 3B085
- Product
- HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 18,000 units
- Distribution
- US Nationwide distribution.
- Recall date
- September 20, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)