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U.S. Department of Health and Human Services

Class 2 Device Recall VAPR TRIPOLAR 90" Degree Suction Electrodes

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  Class 2 Device Recall VAPR TRIPOLAR 90" Degree Suction Electrodes see related information
Date Initiated by Firm November 23, 2015
Date Posted December 23, 2015
Recall Status1 Terminated 3 on April 12, 2017
Recall Number Z-0479-2016
Recall Event ID 72703
510(K)Number K143475  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
Code Information U1509202 and U1509162
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Drive
Raynham MA 02767-5199
For Additional Information Contact Joseph Cipollo
508-880-8100
Manufacturer 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
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Depuy Mitek
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