Smith & Nephew Medical, Ltd.: Device Recall
Recall #Z-0516-2025 · 10/02/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0516-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Smith & Nephew Medical, Ltd.
- Status
- Ongoing
- Date Initiated
- 10/02/2024
- Location
- Hull, United Kingdom
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1589 units
Reason for Recall
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
Product Description
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.
Distribution Pattern
U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.