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Recall Observatory FDA recall evidence

Device product

Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.

Z-2740-2016

August 08, 2016

Class II

Product summary

Firm
Arrow International Inc
Event
Event 74986
Status
Terminated
Classification
Class II
Quantity
690 kits
Official record key
device-enforcement:Z-2740-2016

Official wording

Reason: Shipping carton labeling error.

Code information: Device Listing # D025180

Distribution pattern: Nationwide Distribution to OH, IN, TN, NC, and KY.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling error