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Recall Observatory FDA recall evidence

Device product

Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549

Z-1801-2018

February 26, 2018

Class II

Product summary

Firm
Beaver-Visitec International Inc.
Event
Event 79915
Status
Terminated
Classification
Class II
Quantity
1025
Official record key
device-enforcement:Z-1801-2018

Official wording

Reason: Products were packaged with incorrect labeling,

Code information: Lot number: 6001035

Distribution pattern: US Nationwide and Canada

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrect labeling