Recall Z-1667-2013— Bryan Medical Inc

Name: FDA recall Z-1667-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-17

Class I · Terminated

Class I FDA medical device recall by Bryan Medical Inc, initiated 2013-04-17, terminated 2013-10-29. It names one FDA 510(k) clearance: K893866. 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..

Recalling firm: Bryan Medical Inc
Classification: Class I
Status: Terminated
Initiated: 2013-04-17
Terminated: 2013-10-29
Firm location: Cincinnati, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K893866 — HOOD PEDIATRIC TRACHEOSTOMY TUBEHood Laboratories·cleared 1989-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.