INOvent, Nitric Oxide Delivery System. Model Number 1605-9000-000
FDA device recall Z-1410-06 · posted 2006-08-25 · Terminated
Recall details
- Recalling firm
- INO Therapeutics, Inc.
- Reason for recall
- The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.
- Action taken
- 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
- Status
- Terminated
- Product code
- MRN
- Quantity affected
- 3,123 units
- Distribution
- Worldwide, USA and countries of Canada, Uruguay, Chile, Argentina, Colombia, and Malaysia
- Date initiated
- 2006-06-29
- Date posted
- 2006-08-25
- Date terminated
- 2007-07-16
- Location
- Clinton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATEX-OHMEDA INOVENT DELIVERY SYSTEM (K000186) | Datex-Ohmeda | 2000-02-10 |