RENASYS EDGE Pump Recall Due to Battery Charging Failure Risk
Smith & Nephew recalls 1,589 RENASYS EDGE wound therapy pumps due to battery charging failure if not properly maintained. Affected patients may experience treatment interruption.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a risk-of-harm medical device used for critical wound therapy. Battery charging failure could interrupt necessary treatment, though no illnesses or injuries have been reported to date. The hazard is conditional on improper battery maintenance.
Plain-English summary
The RENASYS EDGE is a negative pressure wound therapy (NPWT) pump made by Smith & Nephew Medical, Ltd. It is used to promote wound healing by removing fluids, including irrigation fluids, body fluids, wound exudate, and infectious materials through suction therapy.
Smith & Nephew is recalling approximately 1,589 units of the RENASYS EDGE pump (Model Numbers 66803126 and 66803126LRC) due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
The affected pumps have been distributed in the United States to Alabama, California, Colorado, Florida, Hawaii, Indiana, Kentucky, Nebraska, New York, Pennsylvania, South Carolina, Tennessee, and Wisconsin, as well as to Canada.
Patients using an affected RENASYS EDGE pump should contact Smith & Nephew Medical, Ltd. or their healthcare provider to verify if their device is included in this recall and discuss appropriate next steps. Healthcare facilities should verify their pumps using the provided model numbers and serial numbers.
The recalled product
- 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.
- Manufacturer
- Smith & Nephew Medical, Ltd.
- Hazard
- battery-depletion
- charging-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Numbers: 66803126
Distribution
Distributed in 13 states:
- AL
- CA
- CO
- FL
- HI
- IN
- KY
- NE
- NY
- PA
- SC
- TN
- WI
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