FDA Medical Device Recalls (openFDA)
INO Therapeutics, Inc.: INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000
- Recall number
- Z-1410-06
- Recalling firm
- INO Therapeutics, Inc.
- Product
- INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000
- Status
- Terminated
- Initiated
- 2006-06-29
- Posted
- 2006-08-25
- Terminated
- 2007-07-16
- Reason
- The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.
- Root cause
- Other
- Action
- 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).
- Quantity
- 3,123 units
- Distribution
- Worldwide, USA and countries of Canada, Uruguay, Chile, Argentina, Colombia, and Malaysia
- Lot, serial or model codes
- All serial numbers for Model #1605-9000-000
- 510(k) numbers
- ["K000186"]
- PMA numbers
- not on file
- Product code
- MRN
- Firm FEI
- 3003323497
- Firm city
- Clinton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28