Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-2279-2017 · Posted None

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeFOZ
Date Initiated2017-03-20
Date Terminated2018-12-18

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.

Firm Action

Arrow International sent an Urgent Medical Device Notification Letter dated April 5, 2017, to affected customers to inform them of the issue. The notice provided safety instructions for using the product and instructed customers to return the enclosed acknowledgement form indicating the notice was received, and fax it to 855-419-8507, Attn: Customer Service or email to [email protected]. Customers with questions were instructed to call 1-866-246-6990. For questions regarding this recall call 610-378-0131.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002507TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORTArrow Intl., Inc. · 2001-03-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑