Class 2 Device Recall CORFLOUltra Jejunal Tube with CORLOCKTwoomey YAdaptor

• Date Initiated by Firm: January 26, 2012
• Date Posted: February 22, 2012
• Recall Status: Terminated on March 21, 2012
• Recall Number: Z-1080-2012
• Recall Event ID: 61036
• 510(K)Number: K821906
• Product Classification: Tubes, gastrointestinal (and accessories) - Product Code KNT
• Product: CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding tube,10 Fr, 36" (91 cm), 3 Gram weighted bolus; individually packaged, 5 tubes per case; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #30-7361; For delivery of enteral nutrition Product Usage: For delivery of enteral nutrition
• Code Information: catalog/reorder #30-7361, lot 46121, expiration: 2016-10
• Recalling Firm/ Manufacturer: Corpak Med Systems; 1001 Asbury Dr; Buffalo Grove IL 60089
• For Additional Information Contact: 800-403-3400
• Manufacturer Reason for Recall: The wrong size Twoomey adapter was packaged with the Jejunal tube.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Corpak MedSystems telephoned customers on January 26, 2012 and sent a follow-up Recall Notification letter dated January 27, 2012 via e-mail reiterating the telephone conversations. Customers were informed of the urgent product recall, the problem and the actions to be taken. Customers were instructed to inspect inventory, segregate any affected product and contact Corpak at 1-800-323-6305 to arrange for the return and replacement of the units found. Customers were advised to complete and return the enclosed acknowledgment form, indicating the number of affected units found in their inventory. Distributors were requested to notify their customers. For questions contact Corpak MedSytems at 1-800-403-3400.
• Quantity in Commerce: 145 units
• Distribution: Worldwide Distribution - USA (nationwide) including the states of Georgia, Indiana, Kentucky, Maryland, Michigan, Minnesota, Tennessee, Utah and the countries of to Sweden and New Zealand.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = KNT