PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 21, 2017 Initiated: May 9, 2017 #Z-2334-2017

Product Description

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

Reason for Recall

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

Details

Recalling Firm
Arrow International Inc
Units Affected
27,485 units distributed in the U.S., 4,371 units distributed internationally
Distribution
Worldwide Distribution - US (nationwide) and Canada
Location
Reading, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Arrow International Inc. Units affected: 27,485 units distributed in the U.S., 4,371 units distributed internationally.
Why was this product recalled?
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 21, 2017. Severity: Moderate. Recall number: Z-2334-2017.