DeRoyal Enteral Safe Feed Tube Recall Due to Incorrect Sizing
DeRoyal Industries is recalling 200 Enteral Safe Feed Tubes labeled as 6.5 FR but containing 5 FR tubes. The recall covers units distributed to Texas and Utah.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error regarding tube size, which is a significant but potentially reversible issue compared to structural failures or contamination.
Plain-English summary
DeRoyal Industries Inc is recalling 200 units of the DeRoyal(R) Enteral Safe Feed Tube, REF 54-2465. The recall is due to a labeling error where tubes labeled as 6.5 FR X 24" actually contained 5 FR X 24" tubes. The affected lot number is 139547.
The product is a nasogastric/oralgastric enteral feeding tube intended for use as directed by a physician. The incorrect sizing could result in the administration of a tube that does not match the physician's prescription or clinical requirements.
The recalled units were distributed in the United States to the states of Texas and Utah. Consumers and healthcare facilities should stop using the affected tubes and contact DeRoyal Industries Inc for further instructions or a replacement.
The recalled product
- 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
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 139547
Distribution
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