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U.S. Department of Health and Human Services

Class 3 Device Recall Corflo AntiI.V. NG Tube

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 Class 3 Device Recall Corflo AntiI.V. NG Tubesee related information
Date Initiated by FirmJune 25, 2008
Date PostedSeptember 21, 2008
Recall Status1 Terminated 3 on September 26, 2008
Recall NumberZ-2306-2008
Recall Event ID 48726
510(K)NumberK043044 
Product Classification Tube - Product Code KNT
ProductCorflo 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.
Code Information catalog/reorder number 20-1225AIV, lot 32601
Recalling Firm/
Manufacturer		 Cardinal Health
1430 Waukegan Rd
Mc Gaw Park IL 60085-6726
For Additional Information ContactMichele B. Donatich R.N.
847-473-1500
Manufacturer 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.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionCardinal 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.
Quantity in Commerce807 tubes
DistributionCalifornia, Illinois, Kentucky and Missouri
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KNT
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