Recall Z-0479-2016— DePuy Mitek, Inc., a Johnson & Johnson Co.
Class II · Terminated
Class II FDA medical device recall by DePuy Mitek, Inc., a Johnson & Johnson Co., initiated 2015-11-23, terminated 2017-04-12. It names one FDA 510(k) clearance: K143475. Product: VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028). 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.
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-23
- Terminated
- 2017-04-12
- Firm location
- Raynham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.