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.
Reported: May 14, 2025 Initiated: March 27, 2025 #Z-1733-2025
Product 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.
Reason for Recall
Due to a potential open seal in the sterile barrier packaging .
Details
- Recalling Firm
- Galt Medical Corporation
- Units Affected
- 100 systems
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.
- Location
- Garland, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Galt Medical Corporation. Units affected: 100 systems.
Why was this product recalled? ▼
Due to a potential open seal in the sterile barrier packaging .
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 14, 2025. Severity: Moderate. Recall number: Z-1733-2025.
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