FDA recall Z-2293-2019

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-07-22

Report date

2019-08-28

Termination date

2020-12-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2293-2019