Benlan Pediatric Feeding Tubes Recalled for Incorrect Size Packaging
Benlan, Inc. is recalling specific lots of 8 FR pediatric feeding tubes that may be packaged with 5 or 6.5 FR tubes instead.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a size discrepancy could lead to improper administration, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Benlan, Inc. is recalling 120 units of MED-RX Single Use Polyurethane Feeding Tubes intended for pediatric use. The affected product is the 8 FR x 36" (91CM) size with an orange radiopaque stripe and enteral connector, manufactured in Canada. The recall covers Lots 114842, 116433, and 118251.
The recall is being conducted because the product may be packaged with a 5 or 6.5 FR tube instead of the labeled 8 FR size. This discrepancy could result in the administration of a tube of the wrong diameter for the intended patient.
The affected units were distributed worldwide, including in the United States (specifically Georgia) and Canada. Consumers and healthcare providers should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer.
The recalled product
- Product
- MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada
- Manufacturer
- Benlan, Inc.
- Category
- Medical Device — Feeding Tubes
- Affected units
- 120
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 (2)
- Lots 114842
- 116433 & 118251
Distribution
Distributed in 1 state:
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