Device 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
Z-2293-2019
Product summary
- Event
- Event 83411
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 cases of 10 units
- Official record key
device-enforcement:Z-2293-2019
Official wording
Reason: Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.
Code information: 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
Distribution pattern: US Nationwide Distribution in the states of N, TX, IL OH, NM, UT. NB, KY, CO
Derived failure modes
-
Unknown
Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.