Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC50

FDA device recall Z-1015-2025 · posted 2025-01-22 · Open, Classified

Recall details

Recalling firm

Trinity Sterile, Inc.

Reason for recall

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

Action taken

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

Status

Open, Classified

Product code

OXQ

Quantity affected

5,940 units

Distribution

US Nationwide distribution in the states of MD, PA, TN and TX.

Date initiated

2024-12-13

Date posted

2025-01-22

Location

Salisbury, MD