Recall Z-0754-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-0754-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-12

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-11-12. FDA's recall record names no specific 510(k) clearance for this event. Product: STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695. Reason: 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..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2024-11-12
Firm location: Northfield, IL, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.