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.
Reported: October 1, 2014 Initiated: August 13, 2014 #Z-2688-2014
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.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 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.
- Location
- Saint Petersburg, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Smith & Nephew, Inc.. Units affected: 2,142 units.
Why was this product recalled? ▼
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 1, 2014. Severity: Moderate. Recall number: Z-2688-2014.
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