Recall Z-0746-2019 ยท FPD Tube, Feeding
DeRoyal Industries Inc
DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician
| Date | Dec 17, 2018 |
| Status | Terminated |
| Reason | Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes. |
| Root cause | Under Investigation by firm |
| Action | The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" dated 12/17/2018 to its consignees by letter on 12/17/2018. The letter described the product, problem and actions to be taken. The consignees were instructed to do the following: 1) Check your inventory for the specific product and lot number listed. 2) If you have affected inventory, complete the Notice of Return Form and return it to recalls@deroyal.com or fax to: 865-362-3716 not later than January 29, 2019. 3) PLEASE COMPLETE THIS FORM AND RETURN IT EVEN IF YOU NO LONGER HAVE ANY INVENTORY.PL EASE CONTACT CUSTOMER SERVICE REPRESENTATIVE AT |
| Quantity | 200 units |
| Distribution | US distribution to states of: TX and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100700 | MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES Benlan, Inc., Dec 13, 2010 |