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Terminated

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 Recall Z-0746-2019 · Posted None

Recall StatusTerminated
Product CodeFPD
Date Initiated2018-12-17
Date Terminated2020-12-16
Product Quantity200 units

Reason for Recall

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

Firm Action

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 [email protected] 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 [email protected] 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 [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

US distribution to states of: TX and UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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