Recall Z-2279-2017— Arrow International Inc

Name: FDA recall Z-2279-2017
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: AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.The ARROWg+ard Blue¿ Catheter permits venous access to the central circulation by way of the femoral, jugular, or subclavian veins. The ARROWg+ard¿ technology is intended to provide protection against catheter-related bloodstream infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). The ARROWg+ard Blue PLUS¿ Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral, jugular, or subclavian veins. The ARROWg+ard¿ technology is intended to provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS¿ catheter in preventing CRBSI's compared to the original ARROWg+ard Blue¿ catheter has not been studied. 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

AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.The ARROWg+ard Blue¿ Catheter permits venous access to the central circulation by way of the femoral, jugular, or subclavian veins. The ARROWg+ard¿ technology is intended to provide protection against catheter-related bloodstream infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). The ARROWg+ard Blue PLUS¿ Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral, jugular, or subclavian veins. The ARROWg+ard¿ technology is intended to provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS¿ catheter in preventing CRBSI's compared to the original ARROWg+ard Blue¿ catheter has not been studied

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.