Recall Z-2281-2019 ยท FPD Tube, Feeding
Canadian Hospital Specialties
MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d) 6.5Fr X 24" (60cm), REF 54-2465R e) 8Fr X 24: (60cm), REF 54-2480R f) 8Fr X 36" (91cm), REF 54-3680R
| Date | Jul 16, 2019 |
| Status | Terminated |
| Reason | The firm received a complaint that the connector detached from the feeding tube. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated the recall by email on 07/16/2019. The notice requested the consignee cease distribution/use of the product, complete and return the product recall response form to arrange for product return and replacement/credit. |
| Quantity | 2870 units |
| Distribution | GA and 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 |