Device evidence

device-recall:cfres:155743

Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters The Arrow¿ Percutaneous Sheath Introducer permits venous access and catheter introduction to the central circulation. The ARROWg+ard¿ antimicrobial surface is intended to help provide protection against sheath-related infections. The sheath is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

Official recall number

Z-2304-2017

Evidence summary

Product code: FOZ
Recall status: Terminated
Event initiated: March 20, 2017
Root cause: Under Investigation by firm
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-2304-2017