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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

IMed, Wolf-Pak, and Tacy Medical Dressing Kits Recalled for Packaging Holes

Agency Publication Date: January 22, 2025
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Summary

Trinity Sterile, Inc. is recalling approximately 14,140 medical dressing change kits and trays sold under the IMed Products, Wolf-Pak, and Tacy Medical brands. The recall was initiated because of the potential for holes in the packaging, which could compromise the sterility of the medical components inside. These kits are used for medical wound care and dressing changes, and using non-sterile components can lead to patient infections. No incidents or injuries have been reported at this time. Consumers should stop using the affected products immediately and contact the manufacturer or their distributor for a replacement or return.

Risk

A hole in the kit packaging allows bacteria and other contaminants to enter, which compromises the sterility of the medical supplies. Using these non-sterile tools during a dressing change increases the risk of serious infection or other complications for the patient.

What You Should Do

  1. This recall affects various IMed Products, Wolf-Pak, and Tacy Medical Dressing Change Kits and Trays with specific lot and model numbers.
  2. Identify if your kit is affected by checking the lot number and model number printed on the package label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled medical kits immediately to prevent the use of potentially non-sterile medical supplies on patients.
  4. Contact Trinity Sterile, Inc. or your specific distributor (IMed Products, Wolf-Pak, or Tacy Medical, Inc.) to arrange for the return, replacement, or correction of any affected inventory in your possession.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: IMed Dressing Change Kit with ChloraPrep 3mL & HaloGUARD (Case of 30)by IMed Products
Model / REF:
IM46062
Lot Numbers:
600022
UDI:
10853155008769

66 cases affected.

Product: Wolf-Pak Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator (Case of 30)by Wolf-Pak
Model / REF:
DC3077LF
Lot Numbers:
600018
UDI:
10857800006841

66 cases affected.

Product: Wolf-Pak Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator (Case of 30)by Wolf-Pak
Model / REF:
DC3080LF
Lot Numbers:
600022
UDI:
10857800006872

132 cases affected.

Product: Wolf-Pak Premium Dressing Change Kit with GuardiVa & Statlock (Case of 30)by Wolf-Pak
Model / REF:
DC5090LF
Lot Numbers:
600088
UDI:
10850007185722

198 cases affected.

Product: Tacy Medical Dressing Change Tray (Case of 20)by Tacy Medical, Inc.
Model / REF:
TM6180CP
Lot Numbers:
600032
UDI:
58500425700020

50 cases affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96068
Status: Active
Manufacturer: Trinity Sterile, Inc.
Sold By: IMed Products; Wolf-Pak; Tacy Medical, Inc.
Manufactured In: United States
Units Affected: 5 products (1,980 units; 1,980 units; 3,960 units; 5,940 units; 280 units)
Distributed To: Maryland, Pennsylvania, Tennessee, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.