FDA recall Z-0516-2025

Smith & Nephew Medical, Ltd. · Class II · device

Product

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.

Reason for recall

Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

Distribution

U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada

Key facts

Status
Ongoing
Initiation date
2024-10-02
Report date
2024-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hull, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2025