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Recall Observatory FDA recall evidence

Device product

Large Volume Abdominal Paracentesis Kit

Z-1297-2018

October 24, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 79294
Status
Terminated
Classification
Class II
Quantity
30,577 eaches
Official record key
device-enforcement:Z-1297-2018

Official wording

Reason: Product packaging may not be completely sealed.

Code information: AK 00376

Distribution pattern: Nationally

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product packaging may not be completely sealed.