Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, 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.
- Company
- Smith & Nephew Inc.
- Recall Initiated
- November 11, 2016
- Recall Number
- Z-1041-2017
- Quantity
- 15,960 units in the US
- Firm Location
- Saint Petersburg, FL
Reason for Recall
Lack of 510k clearance for design modification.
Distribution
Nationwide
Lot / Code Info
Model No. 66800164; All pumps of this model are affected.
Root Cause
No Marketing Application
Action Taken
On letter sent to all their consignees, Smith & Nephew asked to the consignees to removed all existing Renasys Go NPWT Pumps and returned following the instructions on the letter and also removed the affected power supply units identified on the recall letter. Each consignee needs to complete the Acknowledge
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