Recall Z-1080-2012 ยท KNT Tubes, Gastrointestinal (And Accessories)
Corpak Med Systems
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
| Date | Feb 22, 2012 (initiated Jan 26, 2012) |
| Status | Terminated |
| Reason | The wrong size Twoomey adapter was packaged with the Jejunal tube. |
| Root 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 invento |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K821906 | CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP Corpak Medsystems, Jul 13, 1982 |