FDA Recall
Open, Classified
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Recall: Z-2514-2023
·
Initiated August 4, 2023
Recall
- Recall Number
- Z-2514-2023
- Event Number
- 92834
- Firm
- MEDLINE INDUSTRIES, LP Northfield
- FEI Number
- 1417592
- Product Code
- CAF
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- August 4, 2023
- Posted
- September 14, 2023
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753
Description
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Reason
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
Action
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.
Distribution
US Nationwide distribution.
Quantity
18,000 units