Reported May 14, 2025 · Ongoing

Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are…

Galt Medical Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Galt Medical Corporation · 2220 Merritt Dr · Garland, TX · 75041-6137

Is this the product you have?

  • 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.
Lot codes and dates
  • Catalog NumberKIT-051-01
  • UDI-DI code00841268106130
  • Lot Numbers24298473 24190504 INT-101-15
  • UDI-DI code00841268107380
  • Lot Number24284447
Amount recalled
490 units

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.