Trinity Sterile, Inc. recalls Brand Name: Tacy Medical

Potential for hole in package compromising sterility of the medical kit.

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.

• FDA enforcement recordOfficial FDA database entry for Z-1016-2025
• FDA device classification · OXQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5075The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Trinity Sterile, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.