Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, 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 s161019, 161102, 161103, 161118, 161201, 161202, 161205, 161215, 161216, 170109, 170110, 170111, 170202, 17023

Distribution pattern: Nationwide and Canada