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.
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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