Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Introducer Kit- Coaxial Dilator REF: KIT-002-28 Recalled by Galt Medical Corporation Due to Due to a potential open seal in the...
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
Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.
Quantity: 4,280 kits
Why Was This Recalled?
Due to a potential open seal in the sterile barrier packaging.
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