Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Component: No
FDA Recall Z-1014-2025 · Posted 2025-01-22
Advertisement
Recalling FirmTrinity Sterile, Inc.
Recall StatusOpen, Classified
Product CodeOXQ
Date Initiated2024-12-13
Product Quantity3,960 units
Reason for Recall
Potential for hole in package compromising sterility of the medical kit.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of MD, PA, TN and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement