Z-2293-2019Class II

DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24"...

Name: Z-2293-2019 DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24"...
Creator: DeRoyal Industries Inc
Published: 2019-07-22
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2019-07-22 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of 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"... on 2019-07-22. FDA classified it as Class II and gives the reason as "Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2293-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-22
Posted: 2019-08-20
Terminated: 2020-12-14
Recalling firm: DeRoyal Industries, Inc.
Product: 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
Product code: FPD Tube, Feeding
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 180 cases of 10 units
Distribution: US Nationwide Distribution in the states of N, TX, IL OH, NM, UT. NB, KY, CO
Product codes and lots: a) REF 54-2450R, Lot Numbers: 142844, 143130 b) REF 54-2465R, Lot Numbers: 142843 c) REF 54-2480R, Lot Numbers: 142870 d) REF 54-3680R, Lot Numbers: 142842

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2293-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2293-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-28	2019-08-20

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)