Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0094-2021 — Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site

U.S. FDA — Device Enforcement · United States · 2020-08-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0094-2021
Date of alert
2020-08-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Genicon, Inc.
Product category
device
Product type
Devices
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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