Recall Z-2293-2019 ยท FPD Tube, Feeding
DeRoyal Industries Inc
DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24" Polyurethane d) REF 54-3680R, 8 FR x 36" Polyurethane Product Usage: Feeding tube
| Date | Jul 22, 2019 |
| Status | Terminated |
| Reason | Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube. |
| Root cause | Nonconforming Material/Component |
| Action | The firm initiated the recall on 07/22/2019 by letter. The recall requested that the consignee examine their inventory and complete and return the Notice of Return Form. Distributors were directed to notify their customers or provide their customer list to DeRoyal for them to perform the notification. The firm is seeking return of the product. For questions contact your DeRoyal Representative, customer service at 888.938.7828, or email us at recalls@deroyal.com. |
| Quantity | 180 cases of 10 units |
| Distribution | US Nationwide Distribution in the states of N, TX, IL OH, NM, UT. NB, KY, CO |
| 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 |