—#151851

Product

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.

FDA product code: OMP — Negative Pressure Wound Therapy Powered Suction Pump
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K083375
Affected lot / code info: Model No. 66800161 when sold separately, Model No. 66800164 when sold with RENASYS GO NPWT Pump; Serial No. < than 144500875.

Why it was recalled

Lack of 510k clearance for design modification.

Root cause (FDA determination)

No Marketing Application

Action the firm took

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

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 970 Lake Carillon Dr, Ste 110, Saint Petersburg, Florida 33716-1130

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2016-11-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151851. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.