Terumo Medical Corp recalls Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx…

Recall date

June 7, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0225-2018

FDA classification

Class II

Brand / firm

Terumo Medical Corp

Sold / distributed

Nationwide and Canada

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY