Recall Z-1596-2024 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Smith & Nephew Medical, Ltd.
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
| Date | Apr 18, 2024 (initiated Mar 11, 2024) |
| Status | Open, Classified |
| Reason | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
| Root cause | Under Investigation by firm |
| Action | 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+N |
| Quantity | 6895 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223041 | Renasys Edge (66803126) Smith & Nephew Medical Limited, Nov 22, 2022 |