Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile clear polyurethane with orange radiopaque stripe Ente
FDA device recall Z-2306-2008 · posted 2008-09-21 · Terminated
Recall details
- Recalling firm
- Cardinal Health
- Reason for recall
- The male Luer adapter may be the wrong component therefore the feeding set would not be able to be connected to the tube nor would the cap fit securely.
- Action taken
- Cardinal Health notified the accounts who ordered the affected feeding tubes via letter dated 6/25/08, informing them that the feeding tube may have the wrong male Luer adapter component, which can cause leakage around the tube outside of the body. Upon review of the letter, the accounts were requested to inspect their inventory and immediately destroy any affected product found and to telephone Cardinal Health/VIASYS MedSystems Technical Service at 1-800-323-6305 for arrange for credit. Dealers were requested to notify their customers. Any questions were directed to Cardinal Health/VIASYS MedSystems at 800-403-3400, ext. 3473. The accounts were also requested to complete and fax back the enclosed acknowledgement form indicating if they have any remaining inventory of the recalled scissors or not.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 807 tubes
- Distribution
- California, Illinois, Kentucky and Missouri
- Date initiated
- 2008-06-25
- Date posted
- 2008-09-21
- Date terminated
- 2008-09-26
- Location
- Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANTI-I.V. ENTERAL FEEDING SYSTEM (K043044) | Viasys Medsystems | 2005-05-06 |