Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). 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 ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied
FDA Recall Z-1879-2017 · Posted 2017-04-10
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeFOZ
Date Initiated2017-03-17
Date Terminated2020-03-24
Product Quantity310 units
Reason for Recall
Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
Firm Action
Arrow International mailed an Urgent Medical Device Notification Letter dated April 4, 2017, to affected customers to inform them of the issue. Customers were asked to discontinue use immediately and return product by completing the enclosed Recall Acknowledgement Form then emailing it to [email protected] or faxing it to 1-855-419-8507. A Customer Service Representative will provide a Return Goods Authorization Number for the products' return.
For questions regarding this recall call 866-246-6990.
Root Cause
Process control
Distribution Pattern
US Distribution to NJ, IL, and PA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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