RENASYS™ EDGE Negative Pressure Wound Therapy
Brand(s)
Last updated
Summary
Product
RENASYS™ EDGE Negative Pressure Wound Therapy
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| RENASYS™ EDGE Negative Pressure Wound Therapy | More than 10 numbers, contact manufacturer. | 66803126 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Smith & Nephew Medical Ltd.
101 Hessle Road, Hull, Great Britain, HU3 2BN
Published by
Health Canada
Audience
General public
Healthcare
Recall class
Type II
Identification number
RA-76381
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