Recall Z-0516-2025 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Smith & Nephew Medical, Ltd.
RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
| Date | Nov 22, 2024 (initiated Oct 2, 2024) |
| Status | Open, Classified |
| Reason | Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. |
| Root cause | Process control |
| Action | On 10/02/2024, the firm sent via overnight mail an "Urgent Medical Device Correction Notice" to customers informing them of an issue associated with the RENASYS EDGE batteries if not appropriately maintained and charged, the batteries may become depleted and be unable to recharge. Customers are instructed to: 1. Please inspect your inventory and locate any RENASYS. EDGE devices from the listed product and serial numbers enclosed with this Urgent Medical Device Correction Notice, and quarantine them immediately. a. If you are a sales rep, please work with sales leadership to have device upgrad |
| Quantity | 1589 units |
| Distribution | U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223041 | Renasys Edge (66803126) Smith & Nephew Medical Limited, Nov 22, 2022 |