Product Wiki · Recalls · Health Canada — Medical Devices

RENASYS™ EDGE Negative Pressure Wound Therapy — recall 76381

Health Canada — Medical Devices · Canada · 2024-10-23 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
76381
Date of alert
2024-10-23
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
General hospital and personal use
Product type
Medical devices
Reported risk: Smith & Nephew Medical Ltd., has initiated a field action to voluntarily correct RENASYS™ EDGE devices. If the batteries are not appropriately maintained and charged as defined in the IFU (left in storage in an uncharged state), the battery may become depleted and be unable to recharge. The RENASYS™ EDGE device will operate on mains power and deliver therapy as intended. The device will show the charger is connected but will not increase battery charge percentage. Recall start date: October 2, 2024
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/renasystm-edge-negative-pressu

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