FDA Recalls Mispackaged Pediatric Feeding Tubes Due to Labeling Error
The FDA is recalling 1,010 units of pediatric feeding tubes because 8FR PVC tubes were incorrectly packaged in 6.5FR polyurethane packs.
What this means for you
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, but the source text describes a packaging/labeling error without reporting any injuries, illnesses, or hospitalizations. Per the rubric, minor labeling errors or voluntary precautionary recalls without reported harm fall under Moderate severity.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 1,010 units of the Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Catalog Number 461438. This medical device is intended for pediatric feeding. The recall was initiated due to a packaging error where 8FR 16-inch PVC tubes were packaged in 6.5FR 36-inch polyurethane packs, and 8FR 20-inch PVC tubes were packaged in 8FR 20-inch polyurethane packs.
The affected product is identified by Lot Code 521807764X. The distribution pattern includes the United States (specifically California), Australia, and Europe. The agency has classified this as a Class II recall.
Healthcare providers and consumers should stop using the affected feeding tubes and contact the manufacturer or their supplier for instructions on return or replacement. This recall addresses a labeling and packaging discrepancy that could lead to the use of the wrong tube size or type.
The recalled product
- Product
- Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. Intended for pediatric feeding.
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Feeding Tubes
- Affected units
- 1,010
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 Code: 521807764X
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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