Home / Recalls / Galt Medical Corporation / Z-1733-2025

Z-1733-2025 Class II Ongoing

Recalled by Galt Medical Corporation — Garland, TX

Recall Details

Product Type
Devices
Report Date
May 14, 2025
Initiation Date
March 27, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100 systems

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.

Reason for Recall

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

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.

Code Information

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

Other recalls by Galt Medical Corporation

  • Z-1734-2025 Class II — GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneou (March 27, 2025)
  • Z-1732-2025 Class II — B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018- (March 27, 2025)
  • Z-1731-2025 Class II — GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended f (March 27, 2025)
  • Z-1737-2025 Class II — Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15 (March 27, 2025)
  • Z-1736-2025 Class II — Introducer Needle REF NDL-107-04 These needles are used for the percutaneous (March 27, 2025)
  • Z-1735-2025 Class II — Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 0 (March 27, 2025)
  • Z-1969-2023 Class II — Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, IN (May 8, 2023)
  • Z-1968-2023 Class II — Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 (May 8, 2023)
  • Z-0568-2021 Class II — Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Cente (November 16, 2020)
  • Z-2565-2018 Class II — Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; (May 2, 2018)