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Recall Observatory FDA recall evidence

Device product

Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels

Z-2327-2017

May 09, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 77232
Status
Terminated
Classification
Class II
Quantity
27, 485 distributed in the U.S, 4,371 distributed Internationally
Official record key
device-enforcement:Z-2327-2017

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: ASK-04018-CC, ASK-04510-HUM, ASK-04550-UHC, Device Listing D025180

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