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Recall Observatory FDA recall evidence

Device product

1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit

Z-2329-2017

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-2329-2017

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-09803-WBH1, ASK-09903-KH, CDC-09803-1A Device Listing E433883

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