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Recall Observatory FDA recall evidence

Device product

Arrow MAC Two-Lumen Central Venous Access Kit Introducer Catheter The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation

Z-2335-2017

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 U.S., 4,371 units distributed internationally
Official record key
device-enforcement:Z-2335-2017

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: CDC-11242-1A Device Listing D025760

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