FDA-Device2017-06-21Class II
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.
Arrow International Inc
Hazard
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Sold states
Worldwide Distribution - US (nationwide) and Canada
Affected count
27,485 units distributed in U.S., 4,371 units distributed internationally
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use. Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2332-2017Don't want to check this manually?
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