FDA Recalls Mispackaged Pediatric Feeding Tubes from Covidien
The FDA is recalling 1,330 units of pediatric feeding tubes due to packaging errors where different tube sizes were placed in incorrect packages.
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, which typically involves a situation that may cause temporary or medically reversible health consequences. The hazard is a packaging error (mis-labeling/mispackaging) without reported injuries, fitting the Moderate severity criteria for minor labeling or packaging issues.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 1,330 units of the Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Catalog Number 461701. This product is intended for pediatric feeding and was distributed in the United States (specifically California), Australia, and Europe.
The recall was initiated because of a packaging error. The source text indicates that 8FR 16-inch PVC tubes were packaged in 6.5 FR 36-inch Polyurethane packs, and 8FR 20-inch PVC tubes were packaged in 8FR 20-inch Polyurethane packs. This discrepancy in packaging could lead to the administration of the wrong tube size or type.
Healthcare providers and consumers should check their inventory for this specific catalog number and lot code (521808064X). If the product is found, it should be stopped and returned to the distributor or manufacturer for credit.
The recalled product
- Product
- Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Intended for pediatric feeding.
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Feeding Tubes
- Affected units
- 1,330
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: 521808064X
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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