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.
FDA Recall Z-2688-2014 · Posted 2014-09-23
Advertisement
Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeOMP
Date Initiated2014-08-13
Date Terminated2015-08-06
Product Quantity2,142 units
Reason for Recall
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
Firm 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.
Root Cause
No Marketing Application
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement