Z-1410-06

INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000

Name: Z-1410-06 INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000
Creator: INO Therapeutics, Inc.
Published: 2006-06-29
License: https://open.fda.gov/license/

Mallinckrodt Manufacturing LLC / initiated 2006-06-29 / Terminated

FDA source

INO Therapeutics, Inc. began a recall of INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000 on 2006-06-29. The reason FDA records is "The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1410-06
Status: Terminated
Initiated: 2006-06-29
Posted: 2006-08-25
Terminated: 2007-07-16
Recalling firm: Mallinckrodt Manufacturing LLC
Product: INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000
Product code: MRN Apparatus, Nitric Oxide Delivery
Reason for recall: The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.
FDA 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 in commerce: 3,123 units
Distribution: Worldwide, USA and countries of Canada, Uruguay, Chile, Argentina, Colombia, and Malaysia
Product codes and lots: All serial numbers for Model #1605-9000-000

Product code MRN

K000186Class IIDatex-Ohmeda Inovent Delivery SystemDatex-Ohmeda / cleared 2000-02-10

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)