Recall Z-2440-2018 ยท FPD Tube, Feeding
Canadian Hospital Specialties
MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, Canada.
| Date | Jul 13, 2018 (initiated Jun 11, 2018) |
| Status | Terminated |
| Reason | The product may be packaged with the incorrect length of feeding tube as labeled. |
| Root cause | Process control |
| Action | The recalling firm issued a letter dated 6/1/2018 via email on 6/11/2018 to formally notify their customer of the reason for recall, discontinue distribution of the product, and complete the enclosed Product Recall Response Form for return via email. |
| Quantity | 10/10-tube cases |
| Distribution | Distribution was made to GA. The foreign recalling firm also distributed product to Canada. |
| 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 |