—#175111

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

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

Why it was recalled

Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2019-07-22
Terminated: 2020-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175111. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.