Home / Recalls / Smith & Nephew Medical, Ltd. / Z-1596-2024

Z-1596-2024 Class II Ongoing

Recalled by Smith & Nephew Medical, Ltd. — Hull

Recall Details

Product Type: Devices
Report Date: April 24, 2024
Initiation Date: March 11, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6895 units

Product Description

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: 66803139

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 Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Chile.

Code Information

GTIN: (01)05000223501044 Lot Numbers: 1016448, 1016478, 1016537, 1016773, 1017147, 1017417, 1017418, 1017912, 1016044