Fortress Introducer Sheath System Recalls

Fortress Introducer Sheath System 386594 Recall Expanded; 2,500 Units Worldwide Distribution (High-R

Fortress Introducer Sheath System recalled 2,500 units linked to label mispackaging. The devices were distributed worldwide, including 15 U.S. states and numerous international markets. The incorrect pouch label lists the 4F version reference and unique device identifier instead of the packaged 6F version. Healthcare providers must stop use and follow manufacturer recall instructions.