# Major Recall Alert: 10Foreâ„¢ Hemostasis Valve Recalled Due to Manufacturing Quality Concerns
Merit Medical has issued an important recall for its **10Fore™ Hemostasis Valve**, beginning **July 25, 2025**. The recall stems from a manufacturing issue identified during a routine quality assurance inspection, which found that improper handling during the production process could cause damage to the product’s silicone quad ring. This defect poses potential risks for patients and healthcare providers, prompting immediate action by the company. Read on to understand why this recall matters, what it means for you, and the steps to take to ensure safety.
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## Why This Recall is Important
The 10Foreâ„¢ Hemostasis Valve plays a critical role in medical procedures, ensuring proper sealing and minimizing the risk of leaks. However, during a quality assurance examination in February 2025, Merit Medical identified a recurring issue: **the silicone quad ring could become deformed or damaged** if not handled or positioned with care during the manufacturing process. This defect compromises the valve's reliability, potentially leading to performance issues during medical procedures.
### Key Safety Concerns:
- **Product Defect**: The quad ring might not fully seat within its intended position due to manual handling errors during production.
- **Potential Risks**: Deformation or damage to the quad ring could lead to improper function, increasing risks during use.
- **Reason for the Recall**: To address the manufacturing concern and protect users from any potential harm.
The manufacturing defect was identified as a direct result of the manual nature of operator handling during the valve’s production. This discovery highlights the importance of precision in medical device manufacturing, especially for products designed to support life-critical medical functions.
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## Details of the Recall
This **10Foreâ„¢ Hemostasis Valve** recall officially began on **July 25, 2025**, encompassing all affected units produced as part of the faulty work order.
Here’s a breakdown of essential facts about the recall:
- **Category**: Medical Device Recall (Canada)
- **Brand**: 10Foreâ„¢ Hemostasis Valve
- **Product Name**: 10Foreâ„¢ Hemostasis Valve
- **Issue Identified**: Damage to the silicone quad ring due to improper manual handling and placement during production.
- **Recall Start Date**: July 25, 2025
- **Root Cause**: Human error during the assembly process, specifically during the positioning and pressing of the silicone quad ring in the device's y-body.
For additional details, check the official recall notification at [Recalls and Safety Alerts](https://recalls-rappels.canada.ca/en/alert-recall/10foretm-hemostasis-valve).
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## What You Should Do
If you are using or distributing the impacted **10Fore™ Hemostasis Valve**, it’s crucial to take immediate action:
- **Stop Use Immediately**: Halt usage of any affected units and identify if your stock may include impacted devices.
- **Contact Merit Medical**: Reach out to Merit Medical or your distributor for detailed guidance on replacement or compensation.
- **Notify Healthcare Providers**: Ensure all relevant medical personnel are aware of the recall to avoid product use in critical procedures.
If you're unsure whether your product has been affected, consult Merit Medical directly for clarification to prevent any potential risks to patient safety.
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## Stay Safe – Get Instant Recall Alerts
Manufacturing defects in medical devices, like the **10Fore™ Hemostasis Valve**, underscore the importance of being up-to-date on recall alerts to protect users and patients from potential harm. To stay informed about the latest recalls and safety notifications, download our **free app** today. With instant notifications, you’ll never miss critical updates about products that could impact your life or profession.
Don’t wait – **download the app** now and stay one step ahead when it comes to safety!
For more information, visit the [official recall page here](https://recalls-rappels.canada.ca/en/alert-recall/10foretm-hemostasis-valve).
Stay safe, stay informed!