Recall Z-1012-2025 ยท OXQ Dressing Change Tray
Trinity Sterile, Inc.
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
| Date | Jan 22, 2025 (initiated Dec 13, 2024) |
| Status | Open, Classified |
| Reason | Potential for hole in package compromising sterility of the medical kit. |
| Root 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 a |
| Quantity | 1,980 units |
| Distribution | US Nationwide distribution in the states of MD, PA, TN and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.