Recall Z-0725-2019 ยท FPD Tube, Feeding
Canadian Hospital Specialties
MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: 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 1, 2018 |
| Status | Terminated |
| Reason | The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled. |
| Root cause | Under Investigation by firm |
| Action | The firm notified its consignees of the recall by email on 12/01/2018. The letter identified the affected product, problem and actions to be taken. The firm requested return of the product. |
| Quantity | 75 cases of 10 |
| Distribution | US in the states of TN |
| 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 |