Reported Dec 4, 2024 · Ongoing
RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may…
Smith & Nephew Medical, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew Medical, Ltd. · 101 Hessle Road · Hull · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Model Numbers
6680312666803126LRC
- UDI-DI codes05000223498634
- Serial NumbersPE
2,956 of 2,956 codes
PEAB230001PEAE230422PEAF230180PEAG230269PEAH230208PEAH230859PEAJ230484PEAB230002PEAE230423PEAF230181PEAG230271PEAH230209PEAH230861PEAJ230490PEAB230003PEAE230427PEAF230185PEAG230272PEAH230210PEAH230862PEAJ230491PEAB230006PEAE230428PEAF230186PEAG230273PEAH230211PEAH230863PEAJ230492PEAB230011PEAE230429PEAF230188PEAG230275PEAH230212PEAH230865PEAJ230493PEAB230014PEAE230432PEAF230189PEAG230277PEAH230214PEAH230867PEAJ230497PEAB230021PEAE230433PEAF230190PEAG230279PEAH230215PEAH230868PEAJ230499PEAB230022PEAE230434PEAF230199PEAG230280PEAH230216PEAH230871PEAJ230502PEAB230027PEAE230436PEAF230202PEAG230282
- Model Numbers
- Amount recalled
- 1589 units
Where it was sold
Why it was recalled
Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
This product could cause temporary or reversible health problems — stop using it.
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