Bryan Medical Recalls Mislabeled Pediatric Tracheostomy Tubes
Bryan Medical Inc is recalling 5 units of Tracoe Mini 3.0mm pediatric tracheostomy tubes because they were mislabeled as smaller infant tubes.
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 I, which typically indicates a low probability of adverse health consequences, and the source text describes a labeling error without reporting specific injuries or illnesses.
Plain-English summary
Bryan Medical Inc is recalling 5 units of Tracoe Mini 3.0mm tubes intended for pediatric use. These devices are tracheostomy tubes used to provide safe airway access.
The recall was initiated because the pediatric tracheostomy tubes were mislabeled as smaller infant tracheostomy tubes. The affected product is identified by Reference #350-3.0 and Lot #000-1000071752.
The units were distributed in Kentucky and Alabama. Consumers and healthcare providers should stop using the affected devices and contact Bryan Medical Inc for further instructions.
The recalled product
- Product
- Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
- Manufacturer
- Bryan Medical Inc
- Hazard
- Affected units
- 5
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)
- The following product/catalog number and lot number was affects: Ref #350-3.0
- lot #000-1000071752
Distribution
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