B Braun Interventional ELITE HV Hemostasis Valve Introducer System Recall
Galt Medical Corporation is recalling the B Braun Interventional ELITE HV Hemostasis Valve Introducer System (Catalog Number 612802, Model BCL-100-04, Lot S25128171) due to a potential open seal in the sterile barrier packaging. The defect may compromise the sterility of the device.
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 is an FDA Class II recall of a sterile medical device with a compromised barrier function. Although no illnesses or injuries are reported in the source text, the potential for the device to lose sterility poses a risk of infection or harm in invasive vascular procedures, meeting the criterion for High severity.
Plain-English summary
Galt Medical Corporation is recalling approximately 100 units of the B Braun Interventional ELITE HV Hemostasis Valve Introducer System (Catalog Number 612802, Model Number BCL-100-04, Lot Number S25128171). This medical device is used in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
The recall is due to a potential open seal in the sterile barrier packaging. An open seal may compromise the sterile condition of the device, potentially affecting its safety and effectiveness for clinical use.
The affected systems were distributed nationwide in the United States (states of Alabama, Florida, Georgia, Illinois, Massachusetts, Ohio, Pennsylvania, and Utah) and internationally to Canada, Ireland, Israel, Korea, Qatar, and the United Kingdom.
Patients and healthcare facilities should immediately cease use of affected units. Contact Galt Medical Corporation or B Braun for instructions on return or replacement of recalled devices. Healthcare providers should verify lot numbers and consult with their institution's recall management procedures.
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-defect
- contamination-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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