Class 1 Device Recall HUDSON RCI Addipak

• Date Initiated by Firm: August 04, 2023
• Date Posted: September 14, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2514-2023
• Recall Event ID: 92834
• 510(K)Number: K142153
• Product Classification: Nebulizer (direct patient interface) - Product Code CAF
• Product: HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
• Code Information: UDI/DI 140267047147818, Lot code 3B085
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 886-359-1704
• Manufacturer Reason for Recall: Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
• FDA Determined Cause: Process control
• 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.
• Quantity in Commerce: 18,000 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CAF