Smith & Nephew recall
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction…
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. 66800161 when sold separately, Model No. 66800164 when sold with RENASYS GO NPWT Pump; Serial No. < than 144500875.
- Product
- Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction…
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 15,960 units (US )
- Distribution
- Nationwide
- Recall date
- January 25, 2017
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)