INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalat
FDA device recall Z-0583-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Ino Therapeutics
- Reason for recall
- Through the review and monitoring of its complaint data, Ikaria identified a product anomaly with the INOmax DS Model 1003. Ikaria concluded the anomaly risk to the patient safety was low and non reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was concluded that the action should have been reported under 21 CFR & 806.10.
- Action taken
- Ikaria sent a "RECALL- CUSTOMER PRODUCT REMEDIATION" notice dated December 22, 2011 to all affected customers. The letter describes the product, problem, actions taken by the firm. No action was required by customers. The notice served as correspondence to inform customers of the issue. Customers may direct their questions to Ikaria Customer Care at 1-877-566-9466.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MRN
- Quantity affected
- 2446
- Distribution
- Worldwide Distribution-USA (nationwide) and the country of MALAYSIA.
- Date initiated
- 2010-11-30
- Date posted
- 2012-01-11
- Date terminated
- 2012-05-29
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (K061901) | Ino Therapeutics | 2006-12-14 |