Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit Recalled by Terumo Medical Corp Due to An incomplete seal at the chevron end of...
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 Terumo Medical Corp directly.
Affected Products
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY
Quantity: N/A
Why Was This Recalled?
An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Terumo Medical Corp
Terumo Medical Corp 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