Smith & Nephew recalls RENASYS EDGE 300ml canisters with solidifier for NPWT patients due to black particulate matter from carbon filters potentially damaging pumps. Affected units have specific lot numbers.
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Smith & Nephew is recalling RENASYS EDGE 300ml canisters with solidifier for patients using negative pressure wound therapy. Black particles from the carbon filter may damage the pump, so affected units should be checked and disposed of if necessary.
The carbon filter in the canister can release black particulate matter that may enter the NPWT pump. This could cause damage to the pump, but it does not pose a direct risk to the patient's health.
Patients using negative pressure wound therapy (NPWT) with the RENASYS EDGE 300ml canister. Those with specific lot numbers from the list are most at risk.
Check if your canister has the product number 66803139 and lot numbers listed: 1016448, 1016478, 1016537, 1016773, 1017147, 1017417, 1017418, 1017912, 1016044.
Verify your canister's product number (66803139) and lot numbers from the list provided.
Black particulate matter from the carbon filter may enter the NPWT pump and cause damage.
The recall record does not specify a remedy, so check with Smith & Nephew for guidance.
The hazard is limited to potential pump damage, not direct patient injury.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1596-2024 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1596-2024 from Smith & Nephew. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
