Z-1013-2025Class II

Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step...

Name: Z-1013-2025 Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step...
Creator: Trinity Sterile, Inc.
Published: 2024-12-13
License: https://open.fda.gov/license/

Trinity Sterile, Inc. / initiated 2024-12-13 / Open, Classified / root cause: manufacturing process

FDA source

Trinity Sterile, Inc. began a recall of Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software... on 2024-12-13. FDA classified it as Class II and gives the reason as "Potential for hole in package compromising sterility of the medical kit". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1013-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-13
Posted: 2025-01-22
Recalling firm: Trinity Sterile, Inc.
Product: Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No
Product code: OXQ Dressing Change Tray
Reason for recall: Potential for hole in package compromising sterility of the medical kit.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 1,980 units
Distribution: US Nationwide distribution in the states of MD, PA, TN and TX.
Product codes and lots: Model No DC3077LF, UDI-DI 10857800006841, Lot Number 600018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1013-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1012-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-22
Z-1013-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-22
Z-1014-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-22
Z-1015-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-22
Z-1016-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-22

Product code OXQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)