FDA-Device2025-01-01Class II

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

MEDLINE INDUSTRIES, LP - Northfield
Hazard

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.

Sold states
US Nationwide distribution.
Affected count
21,440 total
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0754-2025

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