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Recall Observatory FDA recall evidence

Device product

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

Z-2334-2017

May 09, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 77232
Status
Terminated
Classification
Class II
Quantity
27,485 units distributed in the U.S., 4,371 units distributed internationally
Official record key
device-enforcement:Z-2334-2017

Official wording

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

Code information: Material number: CDA-22122-U1A, CDC-22141-1A CDC-26142-1A Device Listing D025726

Distribution pattern: Worldwide Distribution - US (nationwide) and Canada

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    packaging may not be completely sealed, which may compromise
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    packaging may not be completely sealed, which may compromise sterility