FDA-Device2019-08-28Class II
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
DeRoyal Industries Inc
Hazard
Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.
Sold states
US Nationwide Distribution in the states of N, TX, IL OH, NM, UT. NB, KY, CO
Affected count
180 cases of 10 units
Manufactured in
200 Debusk Ln, N/A, Powell, TN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2293-2019Don't want to check this manually?
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