Renasys Edge recall: Particulate Matter
RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing…
Why was Renasys Edge recalled?
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: (01)05000223501082 Lot Numbers: 1016051, 1017549
- Product
- RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing…
- Recalling firm
- Smith & Nephew Medical, Ltd.
- Quantity
- 675 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile.
- Recall date
- April 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)