medical Class II Updated 2025-05-14

Galt Medical Corporation recalls B Braun Interventional ELITE HV Hemostasis Valve Introducer

Recalled 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.


Hazard / Issue

Due to a potential open seal in the sterile barrier packaging .

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171
View official government recall

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