Z-0746-2019 Class II Terminated
FDA device recall Z-0746-2019 was initiated by DeRoyal Industries Inc on Dec 17, 2018 and is designated Class II. Reason for recall: Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes. The recall status is terminated (terminated Dec 16, 2020). Affected quantity: 200 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 23, 2019
- Initiation Date
- Dec 17, 2018
- Termination Date
- Dec 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200 units
Product 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 for Recall
Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.
Distribution Pattern
US distribution to states of: TX and UT.
Code Information
Lot Number 139547
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0746-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026