Recall Z-1277-2018 ยท FPB Filter, Infusion Line
Halyard Health, Inc
CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.
| Date | Dec 13, 2017 |
| Status | Terminated |
| Reason | The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible within the window of the exit port of the feeding tube. Based on specifications, the transmitting stylet in the NG tube should not be visible within the port window. |
| Root cause | Under Investigation by firm |
| Action | The firm, Halyard, sent an "URGENT: Product Advisory Notice" letter dated 12/13/2017 to its customers on about 12/13/2017. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: Instructions for distributors included to examine unsold inventory for impacted lots, complete and return the Distributor Product Advisory Notice Acknowledgement Form, and send the attached End-User/Customer Product Advisory Notice and Acknowledgement Form to all end user customers who would have potentially received impacted product by email to: monica.k |
| Quantity | 185 cases (10 units per case) |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AR, CA, CO, GA, IA, LA, MI, MN, NM, TX; and country of Germany. Distributed internationally to Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083210 | CORFLO ANTI IV ENTERAL FEEDING TUBE Corpak Medsystems, Dec 29, 2008 |