Z-0479-2016 Class II Terminated
FDA device recall Z-0479-2016 was initiated by DePuy Mitek, Inc., a Johnson & Johnson Co. on November 23, 2015 and is designated Class II. Reason for recall: 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 no… The recall status is terminated (terminated April 12, 2017). Affected quantity: 127.
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2015
- Initiation Date
- November 23, 2015
- Termination Date
- April 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 127
Product Description
VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
Reason for Recall
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
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.
Code Information
U1509202 and U1509162