CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding tube,10 Fr, 36
FDA device recall Z-1080-2012 · posted 2012-02-22 · Terminated
Recall details
- Recalling firm
- Corpak Med Systems
- Reason for recall
- The wrong size Twoomey adapter was packaged with the Jejunal tube.
- Action taken
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 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.
- Date initiated
- 2012-01-26
- Date posted
- 2012-02-22
- Date terminated
- 2012-03-21
- Location
- Buffalo Grove, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORPAK ENTERIC FEEDING TUBE W/GUIDE TIP (K821906) | Corpak Medsystems | 1982-07-13 |