Z-0094-2021Class II

Aquas PowerFlow Tube Set -

Name: Z-0094-2021 Aquas PowerFlow Tube Set -
Creator: Genicon, Inc.
Published: 2020-08-25
License: https://open.fda.gov/license/

Genicon, Inc. / initiated 2020-08-25 / Open, Classified / root cause: design

FDA source

Genicon, Inc. began a recall of Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood... on 2020-08-25. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0094-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-08-25
Posted: 2020-10-09
Recalling firm: Genicon, Inc.
Product: 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 code: N/A
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).
Root cause tag: design
FDA root cause: Device Design
Action: Genicon issued an updated urgent medical device recall notification on August 29,2020 and initial urgent medical device recall notification was sent on August 24, 2020. The notification states the following action to be taken: To Distributors: Please encourage your customers to complete and return the enclosed response form as soon as possible and return the form by e-mail to [email protected]. In addition, if you or your customers have any of the affected devices, contact Genicon Customer Service , to coordinate the return of the product associated with this action at no additional cost. Genicon Customer Service Contact Information Genicon Customer Service Manager +1-407-657-4851, extension #800, Monday through Thursday 9AM-4PM USA Eastern Time Zone. E-mail: [email protected]. To Users: (1)Please confirm whether any of the affected product remains in your inventory by completing the attached Medical Device Recall Response Form and e-mailing it to [email protected]. (2) Should you find affected product in your inventory, do not use them. (3)Please return affected product to Genicon, Inc. (see below contact details). Genicon Customer Service Manager (contact information below) to coordinate the return at no additional cost. NAME, Genicon Customer Service Manager +1-407-657-4851, extension #800, Monday through Thursday 9AM-4PM USA Eastern Time Zone. E-mail: [email protected].
Quantity in commerce: 10808 units
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, IA, IL, IN, MA, MI, MO, NC, OH, TN, VA, WA, WI and the countries of ECUADOR, HONG KONG, QATAR, SAUDI ARABIA, UAE (Dubai), JORDAN, KUWAIT, SOUTH AFRICA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0094-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0094-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-21	2020-10-09

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)