Smith & Nephew recall
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote…
Why was Smith & Nephew recalled?
Lack of 510k clearance for design modification.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 No. 66800164; All pumps of this model are affected.
- Product
- Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote…
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 15,960 units in the US
- Distribution
- Nationwide
- Recall date
- January 25, 2017
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)