Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tearaway Introducer Kit Recalled by Galt Medical Corporation Due to Sheath introducer assemblies could potentially, due to improper...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Galt Medical Corporation directly.
Affected Products
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Quantity: 490
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Galt Medical Corporation
Galt Medical Corporation has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report