B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Galt Medical Corporation
- Reason for Recall:
- Due to a potential open seal in the sterile barrier packaging .
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
Product Codes/Lot Numbers:
Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1733-2025
Related Recalls
Due to a potential open seal in the sterile barrier packaging.
Due to a potential open seal in the sterile barrier packaging .
Due to a potential open seal in the sterile barrier packaging.