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U.S. Department of Health and Human Services

Class 2 Device Recall INOvent, Nitric Oxide Delivery System

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  Class 2 Device Recall INOvent, Nitric Oxide Delivery System see related information
Date Initiated by Firm June 29, 2006
Date Posted August 25, 2006
Recall Status1 Terminated 3 on July 16, 2007
Recall Number Z-1410-06
Recall Event ID 35892
510(K)Number K974562  K000186  
Product Classification Nitric Oxide Delivery System - Product Code MRN
Product INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000
Code Information All serial numbers for Model #1605-9000-000
Recalling Firm/
Manufacturer		 INO Therapeutics, Inc.
6 State Route 173
Clinton NJ 08809-1269
For Additional Information Contact Kate McDermott
908-238-6688
Manufacturer Reason
for Recall		 The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MRN and Original Applicant = DATEX-OHMEDA
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