FDAClass IIAugust 28, 2019

DeRoyal Enteral Safe Feeding Tubes: a) recall

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"…

Why was DeRoyal Enteral Safe Feeding Tubes: a) recalled?

Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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"…
Recalling firm
DeRoyal Industries Inc
Quantity
180 cases of 10 units
Distribution
US Nationwide Distribution in the states of N, TX, IL OH, NM, UT. NB, KY, CO
Recall date
August 28, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls