Brand
Smith & Nephew Medical, Ltd.
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Smith & Nephew Medical, Ltd. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-12-04FDA-DeviceClass IIRENASYS 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.
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
- 2024-04-24FDA-DeviceClass IIRENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
- 2024-04-24FDA-DeviceClass IIRENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
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