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Recall Observatory FDA recall evidence

Device product

VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)

Z-0479-2016

November 23, 2015

Class II

Product summary

Firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Event
Event 72703
Status
Terminated
Classification
Class II
Quantity
127
Official record key
device-enforcement:Z-0479-2016

Official wording

Reason: Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only

Code information: U1509202 and U1509162

Distribution pattern: Worldwide Distribution - US Distribution to the states of : AL, CA, CT, FL, KY, MN, MS, ND, NJ, NM and TX., and to the countries of: France, Netherlands and Norway.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only