Genicon recalls Aquas PowerFlow Tube Sets due to lack of FDA premarket clearance. These surgical irrigation devices may not be safe for use during laparoscopic procedures.
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).
Genicon is recalling Aquas PowerFlow Tube Sets that were sold with specific model numbers and lot numbers. The devices lack FDA premarket clearance, which means they were not approved for safety before being sold.
The device design did not receive proper premarket clearance from the US FDA and lacks a 510(k). This means the device may not be safe for use during surgical procedures as it was not tested for safety before being sold.
Surgical professionals using the Aquas PowerFlow Tube Sets for laparoscopic procedures are affected. Patients undergoing surgery with these devices could be at risk due to the lack of FDA approval.
Check for model numbers 720-005-000 (BPSI SET WITH NO PROBE) or 720-005-001 (BPSI SET 8 VENT PROBE). The lot numbers listed in the recall include I9214-C through I9365-D.
Identify the model number and lot number on your Aquas PowerFlow Tube Set to see if it matches the recalled items.
The device design did not receive proper premarket clearance from the US FDA and lacks a 510(k), meaning it was not approved for safety before being sold.
Model # 720-005-000 (BPSI SET WITH NO PROBE) and Model # 720-005-001 (BPSI SET 8 VENT PROBE) with lot numbers from I9214-C to I9365-D.
The recall record does not specify a remedy, so check the product details to see if it matches the recalled items and contact Genicon for further instructions.
We’ve drafted a message you can send Genicon to request your refund or repair — edit it as you like.
Subject: Recall Z-0094-2021 — Genicon Genicon Hello, I own a Genicon that is covered by recall Z-0094-2021 from Genicon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
