Z-0746-2019Class II

DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The MED-RX...

Name: Z-0746-2019 DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The MED-RX...
Creator: DeRoyal Industries Inc
Published: 2018-12-17
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2018-12-17 / Terminated / root cause: labeling and UDI

FDA source

DeRoyal Industries Inc began a recall of 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... on 2018-12-17. FDA classified it as Class II and gives the reason as "Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0746-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-17
Posted: 2019-01-16
Terminated: 2020-12-16
Recalling firm: DeRoyal Industries, Inc.
Product: 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
Product code: FPD Tube, Feeding
Reason for recall: Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" dated 12/17/2018 to its consignees by letter on 12/17/2018. The letter described the product, problem and actions to be taken. The consignees were instructed to do the following: 1) Check your inventory for the specific product and lot number listed. 2) If you have affected inventory, complete the Notice of Return Form and return it to [email protected] or fax to: 865-362-3716 not later than January 29, 2019. 3) PLEASE COMPLETE THIS FORM AND RETURN IT EVEN IF YOU NO LONGER HAVE ANY INVENTORY.PL EASE CONTACT CUSTOMER SERVICE REPRESENTATIVE AT 865-362-4203 OR EMAIL AT [email protected] FOR RETURN INFORMATION. 4) Once we have received your Notice of Return Form, you will be given credit or replacements as you have indicated on the form. 5) If you have further distributed these products, it is required that your customers be notified of this recall. You may either do this directly and notify us that you have done so, or you may provide us with your customer listing and we will contact them. If you have questions or need assistance with the recall, please contact your DeRoyal Representative, customer service at 888.938.7828, or email us at [email protected].
Quantity in commerce: 200 units
Distribution: US distribution to states of: TX and UT.
Product codes and lots: Lot Number 139547

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0746-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0746-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-16

Product code FPD

K100700Class IIMed-Rx Pediatric Feeding Tubes and AccessoriesBenlan, Inc. / cleared 2010-12-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)