Recall Z-0746-2019— DeRoyal Industries Inc

Name: FDA recall Z-0746-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-17

Class II · Terminated

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2018-12-17, terminated 2020-12-16. It names one FDA 510(k) clearance: K100700. 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. Reason: Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes..

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2018-12-17
Terminated: 2020-12-16
Firm location: Powell, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K100700 — MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIESBenlan, Inc.·cleared 2010-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.