Home / Recalls / Galt Medical Corporation / Z-1737-2025

Z-1737-2025 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
490 units

Product Description

Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.

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: KIT-051-01, UDI-DI code: 00841268106130 Lot Numbers: 24298473 24190504 INT-101-15, UDI-DI code: 00841268107380 Lot Number: 24284447

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-1733-2025 Class II — B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 (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)