—#169992

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

FDA product code: FPD — Tube, Feeding
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K100700
Affected lot / code info: Lot Number 139547

Why it was recalled

Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 recalls@deroyal.com 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 JMARSH@DEROYAL.COM 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 recalls@deroyal.com.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: US distribution to states of: TX and UT.

Timeline

Recall initiated: 2018-12-17
Terminated: 2020-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169992. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.