FDA-Device2024-12-04Class II
RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
Smith & Nephew Medical, Ltd.
Hazard
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
Sold states
U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada
Affected count
1589 units
Manufactured in
101 Hessle Road, Hull, United Kingdom
Products
RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2025Don't want to check this manually?
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