RecallRadar

FDA Device recall Z-1667-2013

Tracoe Mini 3.0mm Tube, for pediatric use

On 2013-07-17 the FDA classified a Class I recall of Tracoe Mini 3.0mm Tube, for pediatric use by Bryan Medical, citing the pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1667-2013
ClassificationClass I
Statusterminated
Initiated2013-04-17
Published2013-07-17
Last updated2026-09-13 11:53 UTC
CompanyBryan Medical
DistributionAL, KY

Product

Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.

Reason

The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.

Identifiers

code_infoThe following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1667-2013%22

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