FDA-Device2025-01-29Class II

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

Trinity Sterile, Inc.
Hazard

Potential for hole in package compromising sterility of the medical kit.

Sold states
US Nationwide distribution in the states of MD, PA, TN and TX.
Affected count
1,980 units
Manufactured in
201 Kiley Dr, Salisbury, MD, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1013-2025

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