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Renasys™ edge negative pressure wound therapy
Official notice
23 Oct 2024
Last checked
23 Oct 2024
An official Health Canada notice concerns Renasys™ edge negative pressure wound therapy. 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 Published 2024-10-23.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76381
Official notice
2024-10-23
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Brand: Smith Nephew Medical, Renasys™ Edge Negative Pressure Wound Therapy.
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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