MEDLINE INDUSTRIES, LP - Northfield recalls STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695

Recall date

November 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0754-2025

FDA classification

Class II

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

US Nationwide distribution.

Why it was recalled

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695