Recall Z-1410-06 ยท MRN Apparatus, Nitric Oxide Delivery
INO Therapeutics, Inc.
INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000
| Date | Aug 25, 2006 (initiated Jun 29, 2006) |
| Status | Terminated |
| 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 |
| Quantity | 3,123 units |
| Distribution | Worldwide, USA and countries of Canada, Uruguay, Chile, Argentina, Colombia, and Malaysia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000186 | DATEX-OHMEDA INOVENT DELIVERY SYSTEM Datex-Ohmeda, Feb 10, 2000 |