Recall Z-0479-2016 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
DePuy Mitek, Inc., a Johnson & Johnson Co.
VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
| Date | Dec 23, 2015 (initiated Nov 23, 2015) |
| Status | Terminated |
| 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 |
| Root cause | Process control |
| Action | DePuy sent an Urgent Field Safety Notice dated November 23, 2015, mailed FEDEx to all affected Customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were asked to take the following steps: 1. Review inventory located within your facility and quarantine any products listed in this product recall notification. Please follow the instructions on the Business Reply Form to return any affected inventory located in your facility. 2. Review, complete, sign and return the attached business reply form in accordance with the directions on |
| Quantity | 127 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143475 | VAPR Tripolar Suction Electrode Depuy Mitek, Apr 3, 2015 |