FDA-Device2025-01-29Class II
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
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
5,940 units
Manufactured in
201 Kiley Dr, Salisbury, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1015-2025Don't want to check this manually?
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