FDA Medical Device Recalls (openFDA)
Bryan Medical Inc: Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
- Recall number
- Z-1667-2013
- Recalling firm
- Bryan Medical Inc
- Product
- Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
- Status
- Terminated
- Initiated
- 2013-04-17
- Posted
- 2013-07-08
- Terminated
- 2013-10-29
- Reason
- The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
- Root cause
- Labeling Change Control
- Action
- The consignees were contacted by telephone and asked to return the recalled product.
- Quantity
- 5 units
- Distribution
- Distributed in KY and AL.
- Lot, serial or model codes
- The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752
- 510(k) numbers
- ["K893866"]
- PMA numbers
- not on file
- Product code
- BTO
- Firm FEI
- 3005803389
- Firm city
- Cincinnati
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28