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Terminated

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

FDA Recall Z-2293-2019 · Posted None

Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeFPD
Date Initiated2019-07-22
Date Terminated2020-12-14
Product Quantity180 cases of 10 units

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.

Firm 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 [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide Distribution in the states of N, TX, IL OH, NM, UT. NB, KY, CO

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100700MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIESBenlan, Inc. · 2010-12-13

Official Source

View FDA Recall →

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

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