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Recall Observatory FDA recall evidence

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

July 22, 2019

Class II

Product summary

Firm
DeRoyal Industries Inc
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

    reason.no_named_rule · v1.0.0

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