Canadian Hospital Specialties Recalls Pediatric Polyurethane Feeding Tubes Due to Labeling Error
Canadian Hospital Specialties is recalling 750 pediatric polyurethane feeding tubes because they may be packaged with a 5FR tube instead of the labeled 6.5FR size.
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, and the hazard is a minor labeling/packaging error where the wrong size tube may be included, which fits the criteria for moderate severity.
Plain-English summary
Canadian Hospital Specialties is recalling 75 cases of 10 MED-RX Polyurethane Feeding Tubes for Pediatric Use. The specific product affected is the 6.5Fr X 24" (60cm) tube with an Orange Radioplaque Stripe and Enteral Connector, Reference 54-2465-R, Lot 139457.
The recall was initiated because the product may be packaged with a 5FR X 24" length feeding tube instead of the 6.5FR X 24" tube indicated on the label. This is a labeling and packaging discrepancy rather than a defect in the tube material itself.
The affected units were distributed in the United States in the state of Tennessee. These tubes are intended for nasogastric or orogastric enteral feeding as directed by a physician. Consumers and healthcare providers should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for…
- Manufacturer
- Canadian Hospital Specialties
- Category
- Medical Device — Feeding Tubes
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 139457
Distribution
Distributed in 1 state:
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