—#72005

Product

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 nasogastric or nasoenteric route.

FDA product code: KNT — Tubes, Gastrointestinal (And Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K043044
Affected lot / code info: catalog/reorder number 20-1225AIV, lot 32601

Why it was recalled

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 (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, Mc Gaw Park, Illinois 60085-6726

Distribution

Distribution pattern: California, Illinois, Kentucky and Missouri

Timeline

Recall initiated: 2008-06-25
Posted by FDA: 2008-09-21
Terminated: 2008-09-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72005. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.