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Recall Observatory FDA recall evidence

Device product

ArrowClarke" PleuraSeal¿ Thoracentesis Kit

Z-1298-2018

October 24, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 79294
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1298-2018

Official wording

Reason: Product packaging may not be completely sealed.

Code information: AK01000 AK-01000-J AK-01000-T ASK-01000-CHP

Distribution pattern: Nationally

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product packaging may not be completely sealed.