FDA Enforcement
Class II
Terminated
DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 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
Recall: Z-0746-2019
·
Reported January 23, 2019
Enforcement
- Recall Number
- Z-0746-2019
- Event ID
- 81818
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- DeRoyal Industries Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 23, 2019
- Initiation Date
- December 17, 2018
- Classification Date
- January 16, 2019
- Termination Date
- December 16, 2020
- Address
- 200 Debusk Ln, Powell, TN, 37849-4703, United States
Description
DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 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
Reason
Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.
Code Info
Lot Number 139547
Distribution
US distribution to states of: TX and UT.
Quantity
200 units