Recall Z-2306-2008 ยท KNT Tubes, Gastrointestinal (And Accessories)
Cardinal Health
Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile clear polyurethane with orange radiopaque stripe Enteral Feeding Tube without Stylet, 5 Fr, 22" long, non-weighted, DEHP and latex free; individually packaged, 10 tubes per carton; Mfg. by Viasys MedSystems, Wheeling, IL 60090 Product is intended for use in those patients who require intermittent or continuous tube feedings via the
| Date | Sep 21, 2008 (initiated Jun 25, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Mixed-up of materials/components |
| Action | 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 Me |
| Quantity | 807 tubes |
| Distribution | California, Illinois, Kentucky and Missouri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043044 | ANTI-I.V. ENTERAL FEEDING SYSTEM Viasys Medsystems, May 6, 2005 |