FDA-Device2017-06-21Class II
1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavia, or femoral veins Catheter, hemodialysis non-implanted
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 the U.S., 4,371 units distributed internationally
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavia, or femoral veins Catheter, hemodialysis non-implanted
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2334-2017Don't want to check this manually?
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