RENASYS EZ Negative Pressure Wound Therapy recall
RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device…
Why was RENASYS EZ Negative Pressure Wound Therapy recalled?
Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model #'s 66800059, all lots since product launched 01/16/2009
- Product
- RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device…
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 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.
- Recall date
- October 1, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)