The Merit 16F Dual-Valved Splittable Sheath Introducer may not split as intended. This may cause bleeding, embolization, or loss of vessel for future access.

http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/dialysis-catheter-recall-merit-medical-removes-16f-dual-valved-splittable-sheath-introducer