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FDA (Device enforcement)Recalled 2024-03-11class ii

Smith & Nephew Medical, Ltd.: RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 6680313

Hazard

Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

Details from the source

Reason for recall: Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Chile. Quantity: 6895 units Lot/code info: GTIN: (01)05000223501044 Lot Numbers: 1016448, 1016478, 1016537, 1016773, 1017147, 1017417, 1017418, 1017912, 1016044

UPC codes

05000223501044

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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