Class 2 Device Recall Medline

• Date Initiated by Firm: July 03, 2023
• Date Posted: August 10, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2366-2023
• Recall Event ID: 92736
• Product Classification: Orthopedic tray - Product Code OJH
• Product: Total Hip Kit, REF DYNJ903275S; surgical convenience kit
• Code Information: UDI/DI: 10195327254582 (unit), 40195327254583 (case); Lot code 23CDC733
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 226-359-1704
• Manufacturer Reason for Recall: The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.
• FDA Determined Cause: Under Investigation by firm
• Action: Medline notified its sole consignee by email on 07/07/2023, The consignee was instructed to destroy any affected product that they may have on hand.
• Quantity in Commerce: 16 kits
• Distribution: US Nationwide distribution in the state of Illinois.
• 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.