Sterile Kelly Hemostat (Medline) – Sterility Seal Weakness (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
Brand
MEDLINE INDUSTRIES, LP Northfield
Lot Codes / Batch Numbers
UDI: 00653160024869 (ea) 60653160024861 (case), Lot 2023011990
Products Sold
UDI: 00653160024869 (ea) 60653160024861 (case); Lot 2023011990
MEDLINE INDUSTRIES, LP Northfield is recalling STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695 due to 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 infectio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On November 25, 2024, the firm notified customers via letters titled IMMEDIATE ACTION REQUIRED. Customers were informed that specific items and lots of Pure Pouch Single-Sterile and Sterile Kits are being recalled due to weak seals. Affected product must be destroyed. The letter included instructions on actions to take to be issued a credit. Customers should immediately check their stock for affected product and quarantine all units. Affected lots should be destroyed. When the recalling firm has received your completed destruction form, your account will be issued a credit, if applicable. If you have any questions, please contact 866-359-1704.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026