Class 2 Device Recall namic Fluid Delivery Sets

• Date Initiated by Firm: March 12, 2024
• Date Posted: May 10, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1807-2024
• Recall Event ID: 94313
• 510(K)Number: K852140
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Namic FLUID DELIVERY SET, REF 91300040
• Code Information: UDI/DI 20193489069096 (box), 10193489069099 (unit), Lot Numbers: 0000113381
• 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: Products have a lack of sterility assurance.
• FDA Determined Cause: Process control
• Action: Medline issued a Medical Device Recall notice to its consignees on 03/12/2024 via email and US Mail. The notice explained the issue, potential risk, and requested destruction of the affected product. Those who further distributed the product were directed to notify those to whom they shipped the product.
• Quantity in Commerce: 50 units
• Distribution: US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.
• 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 = FPA and Original Applicant = NORTH AMERICAN INSTRUMENT CORP.