Class 2 Device Recall IMed Products

• Date Initiated by Firm: December 13, 2024
• Date Posted: January 22, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1012-2025
• Recall Event ID: 96068
• Product Classification: Dressing change tray - Product Code OXQ
• Product: Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No
• Code Information: Model No IM46062, UDI-DI 10853155008769, Lot Number 600022
• FEI Number: 1000123297
• Recalling Firm/ Manufacturer: Trinity Sterile, Inc.; 201 Kiley Dr; Salisbury MD 21801-2249
• For Additional Information Contact: Douglas B. Kraemer; 1-410-8605123
• Manufacturer Reason for Recall: Potential for hole in package compromising sterility of the medical kit.
• FDA Determined Cause: Process control
• Action: On December 13, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to direct accounts. Action required: Our records indicate you have may have received and/or distributed product that is subject to this recall. We are now notifoing you to take the following actions: 1, Inspect your inventory for the affected product lots. If you have affected product lots in inventory, discontinue use immediately. 2. Notify Additional Users. If you have further distributed any of the items referenced in this notification, you must notify those downstream customers of this recall. Have those users return any affected product to you. Please include these additional users'quantities on your response form. 3. Notify Trinity. Please complete the enclosed Recall Acknowledgement form as soon as possible, indicating whether you do or do not have inventory and fax it to 410-860-2913 or e-mail it to customerseruice@tri nitysterile.com. 4. Return the affected product. Once Trinity receives your completed Recall Acknowledgement form, a customer seryice representative will contact you with a Return Materials Authorization (RMA) number covering your inventory and will provide instruction for the return of products. Trinity is committed to providing high-quality, safe, and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have experienced an adverse event associated with this product, please call Customer Service and/or report the event to FDA's MedWatch Adverse Event Reporting program online. If you have any questions, please contact Customer Service at 410-860-5123.
• Quantity in Commerce: 1,980 units
• Distribution: US Nationwide distribution in the states of MD, PA, TN and 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.