Smith & Nephew—RENASYS GO Negative-Pressure Wound Therapy Pumps and External Power Supply Units: Manufacturer Withdraws Product from the Market
November 23, 2016 | Strategic Insights for Health System
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In a November 11, 2016, Urgent Medical Device Removal Notice letter submitted by an ECRI Institute member hospital, Smith & Nephew states that it is removing all the above pumps, which should have been removed from service in July 2014 because of the need for the firm to pursue 510(k) clearance after a design change, and the above external power units, which may overheat and induce electric shock during use with the above NPWT pumps. Smith & Nephew also states that it does not believe that a safety or health risk is associated with this action because distribution of the above pumps and power supply units ceased in July 2014 and accessory kits have not been available. The manufacturer has not confirmed the...