Class 2 Device Recall Medline

• Date Initiated by Firm: October 19, 2023
• Date Posted: September 30, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0533-2024
• Recall Event ID: 93306
• Product Classification: Bag, urine collection, leg, for external use, sterile - Product Code FAQ
• Product: Medline Leg bag, REF DYND12574
• Code Information: UDI/DI 40080196990338 (case), 10080196990337 (insert), Lot Numbers: 48623040001, 48623050001, 48623060001, 48623080001
• 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: Undeclared latex
• FDA Determined Cause: Labeling mix-ups
• Action: Medline issued a recall notice to its consignees on 10/16/2023 by USPS First Class Mail. The notice explained the issue, potential risk user, and requested destruction of the affected product at the consignee. Anyone who further distributed the product is directed to notify those to whom the product was distributed.
• Quantity in Commerce: 28942 devices
• Distribution: US and Panama
• 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.