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
Reported: January 29, 2025 Initiated: December 13, 2024 #Z-1015-2025
Product 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
Reason for Recall
Potential for hole in package compromising sterility of the medical kit.
Details
- Recalling Firm
- Trinity Sterile, Inc.
- Units Affected
- 5,940 units
- Distribution
- US Nationwide distribution in the states of MD, PA, TN and TX.
- Location
- Salisbury, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Trinity Sterile, Inc.. Units affected: 5,940 units.
Why was this product recalled? ▼
Potential for hole in package compromising sterility of the medical kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2025. Severity: Moderate. Recall number: Z-1015-2025.
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