FDA-Device2017-12-20Class II
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
Terumo Medical Corp
Hazard
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.
Sold states
Nationwide and Canada
Affected count
N/A
Manufactured in
2101 Cottontail Ln, N/A, Somerset, NJ, United States
Products
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0226-2018Don't want to check this manually?
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