Z-2688-2014 Class II Terminated
FDA device recall Z-2688-2014 was initiated by Smith & Nephew, Inc. on Aug 13, 2014 and is designated Class II. Reason for recall: Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification. The recall status is terminated (terminated Aug 6, 2015). Affected quantity: 2,142 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 1, 2014
- Initiation Date
- Aug 13, 2014
- Termination Date
- Aug 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,142 units
Product Description
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.
Reason for Recall
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
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.
Code Information
Model #'s 66800059, all lots since product launched 01/16/2009
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2688-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026