Reported Oct 21, 2020 · Ongoing
Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during…
Genicon, Inc.
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: Genicon, Inc. · 6869 Stapoint Ct Ste 112 · Winter Park, FL · 32792-6603
Is this the product you have?
- Aquas
- PowerFlow Tube Set - Product UsageThe device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published 720-005-000(BPSI SET WITH NO PROBE) 720-005-001Lot # I9214-C (BPSI SET 8 VENT PROBE) — Lot Numbers: I8881-D I8873-D I9057-D I9058-D I9209-D I9213-D I9227-D I9235-D I9236-D I9237-D I9278-D I9280-D I9282-D I9283-D I9299-D I9309-D I9322-D I9324-D I9356-D I9358-D I9360-D I9361-D I9362-D I9363-D I9364-D I9365-D - Amount recalled
- 10808 units
Where it was sold
Why it was recalled
The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k).
This product could cause temporary or reversible health problems — stop using it.
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