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Recall Observatory FDA recall evidence

Device product

CUTTING ELECTRODE BIPO 24.5FR, REF 4653.1323

Z-2246-2021

June 25, 2021

Class II

Product summary

Firm
Richard Wolf GmbH
Event
Event 88249
Status
Terminated
Classification
Class II
Quantity
20 boxes
Official record key
device-enforcement:Z-2246-2021

Official wording

Reason: Product labeled as Cutting Electrode may contain BIVAP electrode.

Code information: Lot Number 21002858

Distribution pattern: US Nationwide Distribution in the states of CA, CO, IN, MA, NH

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product labeled as Cutting Electrode may contain BIVAP electrode.