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

Class I - Dangerous
🏥 Medical Devices Recalled: December 13, 2024 Trinity Sterile Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Model No DC5090LF, UDI-DI 10850007185722, Lot Number 600088
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Trinity Sterile, Inc.
Reason for Recall:
Potential for hole in package compromising sterility of the medical kit.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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

Product Codes/Lot Numbers:

Model No DC5090LF, UDI-DI 10850007185722, Lot Number 600088

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1015-2025

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