FDA Medical devices recall ·
B Braun Interventional ELITE HV Hemostasis Valve Introducer System recall
- Recall number
- Z-1733-2025
- Date
- (initiated March 27, 2025)
- Company / brand
- Galt Medical Corporation
2220 Merritt Dr, Garland, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 100 systems
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Due to a potential open seal in the sterile barrier packaging .
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171
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.
States: Alabama Florida Georgia Illinois Massachusetts Ohio Pennsylvania Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1733-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.