Canadian Hospital Specialties Recalls Pediatric Feeding Tubes with Incorrect Length Labeling
Canadian Hospital Specialties is recalling specific lots of pediatric feeding tubes because they may be packaged with the incorrect length as labeled.
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 labeling error regarding product dimensions. No injuries or illnesses are reported, fitting the criteria for a moderate severity recall involving minor labeling errors or low-risk issues.
Plain-English summary
Canadian Hospital Specialties is recalling 10-tube cases of MED-RX 5Fr x 16 inch (40cm) Polyurethane Feeding Tubes for pediatric use. The recall involves Lot #135137. The product is sterile and packaged with an orange radiopaque stripe and enteral connector.
The recall was initiated because the product may be packaged with the incorrect length of feeding tube as labeled. This labeling discrepancy could result in the use of a tube that does not match the intended specifications for the patient.
Distribution was made to Georgia, and the foreign recalling firm also distributed the product to Canada. Consumers and healthcare providers should stop using the affected product and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, Canada.
- Manufacturer
- Canadian Hospital Specialties
- Category
- Medical Device — Feeding Tubes
- Hazard
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 #135137
Distribution
Distributed in 1 state:
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