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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes."
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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