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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal Enteral Safe Feeding Tube

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  Class 2 Device Recall DeRoyal Enteral Safe Feeding Tube see related information
Date Initiated by Firm July 22, 2019
Create Date August 20, 2019
Recall Status1 Terminated 3 on December 14, 2020
Recall Number Z-2293-2019
Recall Event ID 83411
510(K)Number K100700  
Product Classification Tube, feeding - Product Code FPD
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
Code Information 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 
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
Manufacturer 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.
FDA Determined
Cause 2		 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 recalls@deroyal.com.
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPD and Original Applicant = BENLAN, INC.
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