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
Recall
- Recall Number
- Z-1597-2024
- Event Number
- 94248
- Firm
- Smith & Nephew Medical, Ltd.
- FEI Number
- 3002808194
- Product Code
- OMP
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- March 11, 2024
- Posted
- April 18, 2024
- Address
- 101 Hessle Road, Hull United Kingdom
Description
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
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Smith & Nephew Medical Ltd. issued Urgent Medical Device Recall Notice R-2024-02 on March 11, 2024 via overnight mail. Letter states reason for recall, health risk and action to take: Based on the regulatory classification and degree of hazard, this field action extends to the retail level. Therefore, it is not required to communicate this notice to the patient at the consumer level. If your customer contacts you regarding a pump failure: 1. Contact S+N Clinical Hotline (800-876-1261) with any questions. 2. Please ensure you provide a replacement as soon as possible. Replacement Stock. Smith+Nephew is supplying replacement stock quantities in parallel with this notice. Please contact [email protected] if you have any questions. If you have any questions or concerns regarding this recall please contact [email protected].
Worldwide distribution - US Nationwide and the countries of Canada, Chile.
675 units