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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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