Recall Z-0516-2025
Smith & Nephew Medical, Ltd. · initiated October 2, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model Numbers: 66803126, 66803126LRC UDI-DI codes: 05000223498634 Serial Numbers: PEAB230001 PEAE230422 PEAF230180 PEAG230269 PEAH230208 PEAH230859 PEAJ230484 PEAB230002 PEAE230423 PEAF230181 PEAG230271 PEAH230209 PEAH230861 PEAJ230490 PEAB230003 PEAE230427 PEAF230185 PEAG230272 PEAH230210 PEAH230862 PEAJ230491 PEAB230006 PEAE230428 PEAF230186 PEAG230273 PEAH230211 PEAH230863 PEAJ230492 PEAB230011 PEAE230429 PEAF230188 PEAG230275 PEAH230212 PEAH230865 PEAJ230493 PEAB230014 PEAE230432 PEAF230189 PEAG230277 PEAH230214 PEAH230867 PEAJ230497 PEAB230021 PEAE230433 PEAF230190 PEAG230279 PEAH230215 PEAH230868 PEAJ230499 PEAB230022 PEAE230434 PEAF230199 PEAG230280 PEAH230216 PEAH230871 PEAJ230502 PEAB230027 PEAE230436 PEAF230202 PEAG230282 PEAH230217 PEAH230872 PEAJ230505 PEAB230028 PEAE230437 PEAF230203 PEAG230283 PEAH230218 PEAH230874 PEAJ230512 PEAB230032 PEAE230438 PEAF230208 PEAG230285 PEAH230219 PEAH230875 PEAJ230513 PEAB230033 PEAE230439 PEAF230209 PEAG230287 PEAH230220 PEAH230876 PEAJ230515 PEAB230036 PEAE230440 PEAF230211 PEAG230288 PEAH230221 PEAH230877 PEAJ230525 PEAB230037 PEAE230441 PEAF230212 PEAG230289 PEAH230222 PEAH230879 PEAJ230526 PEAB230039 PEAE230442 PEAF230217…
Reason for recall
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
FDA-determined cause: Process control
Action taken
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 fieldactions@smith-nephew.com. 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)
Details
- Recall number
- Z-0516-2025
- Initiated
- October 2, 2024
- Posted by FDA
- November 22, 2024
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 1589 units
- Distribution
- U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada
- Recalling firm
- Smith & Nephew Medical, Ltd., Hull