Galt Medical Corporation: Medical Device Recall in 2025 - (Recall #: Z-1733-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 27, 2025

Date Posted: May 14, 2025

Recall Number: Z-1733-2025

Event ID: 96622

Reason for Recall:

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

Status: Ongoing

Product Quantity: 100 systems

Code Information:

Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated