Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY

Reason: 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.

Code information: Lot 161110, 161214, 170119

Distribution pattern: Nationwide and Canada