Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, 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 170316

Distribution pattern: Nationwide and Canada