Z-0754-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2025
- Initiation Date
- November 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,440 total
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI: 00653160024869 (ea) 60653160024861 (case); Lot 2023011990