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.
- Company
- Smith & Nephew Inc.
- Recall Initiated
- November 11, 2016
- Recall Number
- Z-1042-2017
- Quantity
- 15,960 units (US )
- Firm Location
- Saint Petersburg, FL
Reason for Recall
Lack of 510k clearance for design modification.
Distribution
Nationwide
Lot / Code Info
Model No. 66800161 when sold separately, Model No. 66800164 when sold with RENASYS GO NPWT Pump; Serial No. < than 144500875.
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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