🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: August 25, 2020 Genicon Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Model # 720-005-000 (BPSI SET WITH NO PROBE); Lot # I9214-C Model # 720-005-001 (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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Genicon, Inc.
Reason for Recall:
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).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Model # 720-005-000 (BPSI SET WITH NO PROBE); Lot # I9214-C Model # 720-005-001 (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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0094-2021

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