INO Therapeutics, Inc. INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000
Brand
INO Therapeutics, Inc.
Lot Codes / Batch Numbers
All serial numbers for Model #1605-9000-000
Products Sold
All serial numbers for Model #1605-9000-000
INO Therapeutics, Inc. is recalling INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000 due to The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.
Recommended Action
Per FDA guidance
On June 29, 2006, the firm sent a letter to its consignees advising them to visually verify that the Kel F tip is in place before attempting to connect either of the high pressure hoses to the INOmax cylinders. INO advised that if the tip was not in place, the operator should immediately replace the tip before attaching the hoses. On July 5, 2005, the firm sent a second letter to their consignees with extra Kel F tips and existing instructions from the INOvent Operation & Maintenance Manual outlining the proper replacement procedure for the tips. The firm is following with telephone contact to assure that the letters were delivered to the proper person(s).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026