Recall Z-2261-2017— Arrow International Inc

Name: FDA recall Z-2261-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-20

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-03-20, terminated 2018-12-18. It names one FDA 510(k) clearance: K002507. Product: Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis 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. Reason: 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..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-03-20
Terminated: 2018-12-18
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K002507 — TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORTArrow Intl., Inc.·cleared 2001-03-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis 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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.