Medical Introducer System Recalled for Potential Compromised Sterile Packaging
Galt Medical Corporation is recalling the B Braun Interventional ELITE HV Hemostasis Valve Introducer System due to a potential open seal in the sterile barrier packaging, which could compromise sterility. Approximately 100 systems are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves a compromised sterile barrier on an intravascular device, creating a significant infection risk. Although no illnesses or injuries have been reported, the product poses a risk of harm per the FDA rubric for high-risk devices with potential serious complications.
Plain-English summary
Galt Medical Corporation is recalling the B Braun Interventional ELITE HV Hemostasis Valve Introducer System (Model BCL-100-04, Catalog Number 612802) due to a potential open seal in the sterile barrier packaging. This introducer system is used in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
A compromised sterile barrier could allow bacterial contamination of the device before use, potentially leading to infection if the non-sterile device is inserted into a patient's blood vessels.
The recalled devices have lot number S25128171 and were distributed worldwide, including to U.S. states of Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, and Utah, as well as to Canada, Ireland, Israel, Korea, Qatar, and the United Kingdom. Approximately 100 systems are affected.
Healthcare facilities and providers who have received this product should stop using affected units immediately and contact Galt Medical Corporation. Patients who may have received this device should consult their healthcare provider.
The recalled product
- 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.
- Manufacturer
- Galt Medical Corporation
- Hazard
- sterile-barrier-breach
- contamination-risk
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171
Distribution
Distributed nationwide across the United States.
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