Class II

Medical Device Recall: RENASYS 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

Smith & Nephew Medical, Ltd. · March 11, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

675 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1597-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.