Arrow International Inc recalls Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety F…

Recall date

March 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2304-2017

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.