HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
This recall is currently active, issued September 14, 2023. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- August 4, 2023
- Posted
- September 14, 2023
- Recall Number
- Z-2514-2023
- Quantity
- 18,000 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI/DI 140267047147818, Lot code 3B085
Root Cause
Process control
Action Taken
Medline issued a recall notice on 08/04/2023 to its consignees by mail and email. The notice explained the problem with the product, risk to use, and requested all affected product be destroyed. Distributors are directed to notify their customers and have the customers document and destroy any affected product. This should be included the customers quantities on the distributor response form.