Home / Recalls / Galt Medical Corporation / Z-1969-2023

Z-1969-2023 Class II Ongoing

Recalled by Galt Medical Corporation — Garland, TX

Recall Details

Product Type
Devices
Report Date
June 21, 2023
Initiation Date
May 8, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6036

Product Description

Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)

Reason for Recall

Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH, GA, MA, NV, CA, NY, NJ and the countries of UK, AU, TR, FR, CH, NO.

Code Information

REF/UDI-DI/LOT (Expiration): INT-028-27 (OEM)/22136556(2/28/2026); INT-105-25/00841268101845/23032145(12/28/2026), 22339238(10/03/2026), 22266856(8/25/2026), 23132602(4/04/2027), 23019935(12/13/2026), 22182660(6/13/2026); INT-106-09/00841268102156/23033942(12/28/2026), 22335239(10/03/2026), 22112754(3/14/2026), 21313293(11/11/2021), 21148681(5/03/2025), 22203491(7/07/2026), 21330748(10/27/2025), 21232023(8/02/2025), 22280971(8/30/2026); INT-106-12/00841268102187/23068151(2/21/2027); INT-106-17/00841268102231/23033947 (12/06/2026), 23167613(4/03/2027); DSS-007-04 (bulk)/PRCGM047382; DSS-007-05 (bulk)/PRCGM050270; DSS-010-065 (bulk)/PRCGM040042; DSS-012-07 (bulk)/PRCGM039532, PRCGM039096

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-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-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-2563-2018 Class II — Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15, (May 2, 2018)