The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1969-2023·Announced 2023-06-21

Tearaway Introducer Set Recall Due to Potential Luer Connection Failure

Galt Medical Corporation is recalling Tearaway Introducer Sets due to potential cracks or dislodgement of the luer connection during use. The defect, linked to improper storage conditions, could render the device unusable.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving a critical component (luer connection) that could crack or dislodge during use, creating a risk-of-harm situation despite no reported illnesses or injuries to date.

Plain-English summary

Galt Medical Corporation is recalling Tearaway Introducer Sets with multiple REF codes (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) in bulk format. Approximately 6,036 units are affected by this Class II recall.

The luer connection portion of the dilator hub can crack or dislodge during use due to improper storage conditions. When this occurs, the dilator component becomes unusable and requires replacement with a functional device.

These devices were distributed worldwide, with US distribution in Pennsylvania, Utah, Florida, Ohio, Georgia, Massachusetts, Nevada, California, New York, and New Jersey, as well as internationally to the United Kingdom, Australia, Turkey, France, Switzerland, and Norway.

Healthcare facilities and users who have this product in stock should discontinue use and contact Galt Medical Corporation for product replacement or additional guidance.

The recalled product

Product
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)
Manufacturer
Galt Medical Corporation
Category
Medical Device — Catheter Introducer
Hazard
Affected units
6,036

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Galt Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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