| Class 2 Device Recall RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) | |
Date Initiated by Firm | August 13, 2014 |
Date Posted | September 23, 2014 |
Recall Status1 |
Terminated 3 on August 06, 2015 |
Recall Number | Z-2688-2014 |
Recall Event ID |
69137 |
510(K)Number | K082426 |
Product Classification |
negative pressure wound therapy Powered suction pump - Product Code OMP
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Product | RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing. |
Code Information |
Model #'s 66800059, all lots since product launched 01/16/2009 |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. 970 Lake Carillon Dr Ste 110 Saint Petersburg FL 33716-1130
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For Additional Information Contact | 800-876-1261 |
Manufacturer Reason for Recall | Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification. |
FDA Determined Cause 2 | No Marketing Application |
Action | All RENASYS EZ Products will be removed from the field and customers will be transitioned to other product. On August 13, 2014 the firm sent an "Urgent- Medical Device Removal RENASYS EZ" notification via FedEx overnight asking that the use of the RENASYS EZ should be immediately discontinued and the device should be returned to Smith & Nephew. If you have questions, please reach out to your Customer Care representative or call 1-800-876-1261 Monday through Friday, 8:00 AM to 6:00 PM, Eastern Time. |
Quantity in Commerce | 2,142 units |
Distribution | Worldwide Distribution- US (nationwide) including MA, MN, NY and Puerto Rico; Canada, Mexico, Dubai, Australia, Chile, Colombia, Germany, France, England, Spain, Italy, Norway, Hong Kong, Shanghai, New Zealand, South Africa, Singapore, Japan, Thailand and the Caribbean Islands. |
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 = OMP
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