| Class 2 Device Recall VAPR TRIPOLAR 90" Degree Suction Electrodes | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GEI
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