Device Recall Reprocessed Ethicon Xcel Trocar Sleeve

Lot number 3574704 UDI Code: (01)00885825014421(17)180310(10)3574704 Model Number: CB5ST (labeled as CB5LT)

Gastroenterology-Urology Devices

2

No

U.S. Nationwide Distribution to the following states of:: NV, NM, TX, and MI.

Stryker || Sustainability Solutions || CB5LT || Ethicon Endo-Surgery, Inc. || Excel Trocar Sleeve || w/Stability Sleeve || 5mm x 100mm || Reprocessed by Stryker Sustainability Solutions || Product Usage: || The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.