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Recall Observatory FDA recall evidence

Device product

DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465 A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician

Z-0746-2019

December 17, 2018

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 81818
Status
Terminated
Classification
Class II
Quantity
200 units
Official record key
device-enforcement:Z-0746-2019

Official wording

Reason: Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.

Code information: Lot Number 139547

Distribution pattern: US distribution to states of: TX and UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.