Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
Recall
- Recall Number
- Z-1015-2025
- Event Number
- 96068
- Firm
- Trinity Sterile, Inc.
- FEI Number
- 1000123297
- Product Code
- OXQ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- December 13, 2024
- Posted
- January 22, 2025
- Address
- 201 Kiley Dr, Salisbury, MD, 21801-2249
Description
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600088, 198 cases affected. Component: No
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.
US Nationwide distribution in the states of MD, PA, TN and TX.
5,940 units