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.
Recall
- Recall Number
- Z-0516-2025
- Event Number
- 95558
- Firm
- Smith & Nephew Medical, Ltd.
- FEI Number
- 3002808194
- Product Code
- OMP
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- October 2, 2024
- Posted
- November 22, 2024
- Address
- 101 Hessle Road, Hull United Kingdom
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.
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
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 upgraded or returned. b. If you are a distributor/DME, your Care Continuum Director will contact you with next steps once you submit the completed Acknowledgment Form. Note: 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. 2. Complete Correction Acknowledgement Form and submit to [email protected]. Firm's contact information: Smith & Nephew, Inc. Global Field Actions 1450 E Brooks Road Memphis, TN 38116 www.smith-nephew.com T: + 1 901 396 2121 T: 1 800 821 5700 (USA toll free)
U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada
1589 units