FDA recall Z-0754-2025

Product

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.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-11-12

Report date

2025-01-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

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