VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
This recall has been terminated (originally issued December 23, 2015).
- Recall Initiated
- November 23, 2015
- Posted
- December 23, 2015
- Terminated
- April 12, 2017
- Recall Number
- Z-0479-2016
- Quantity
- 127
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
U1509202 and U1509162
Root Cause
Process control
Action Taken
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 the business reply form within 5 business days of receipt of this notification. 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any potentially affected product has been forwarded to another facility, contact the firm. 5. Keep a copy of this notice. For further questions please call (508) 880-8100.