Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 M
Summary
The FDA issued a Class II for Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressin by Trinity Sterile, Inc.. Reason: Potential for hole in package compromising sterility of the medical kit..
Details
Source
Device Recall
External ID
Z-1013-2025
Action Date
2025-01-29
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Model No DC3077LF, UDI-DI 10857800006841, Lot Number 600018
Quantity Affected: 1,980 units
Reason for Recall
Potential for hole in package compromising sterility of the medical kit.
Distribution
US Nationwide distribution in the states of MD, PA, TN and TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-13
Company
Salisbury, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Trinity Sterile, Inc. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Trinity Sterile, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Trinity Sterile, Inc. have FDA actions?
Trinity Sterile, Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1013-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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