Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.
Reported: January 25, 2017 Initiated: November 11, 2016 #Z-1042-2017
Product Description
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.
Reason for Recall
Lack of 510k clearance for design modification.
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 15,960 units (US )
- Distribution
- Nationwide
- Location
- Saint Petersburg, FL
Frequently Asked Questions
What product was recalled? ▼
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.. Recalled by Smith & Nephew, Inc.. Units affected: 15,960 units (US ).
Why was this product recalled? ▼
Lack of 510k clearance for design modification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 25, 2017. Severity: Moderate. Recall number: Z-1042-2017.
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