INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000
FDA Recall Z-1410-06 · Posted 2006-08-25
Advertisement
Recalling FirmINO Therapeutics, Inc.
Recall StatusTerminated
Product CodeMRN
Date Initiated2006-06-29
Date Terminated2007-07-16
Product Quantity3,123 units
Reason for Recall
The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.
Firm 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).
Root Cause
Other
Distribution Pattern
Worldwide, USA and countries of Canada, Uruguay, Chile, Argentina, Colombia, and Malaysia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement