Date Initiated by Firm |
April 17, 2013 |
Date Posted |
July 08, 2013 |
Recall Status1 |
Terminated 3 on October 29, 2013 |
Recall Number |
Z-1667-2013 |
Recall Event ID |
65449 |
510(K)Number |
K893866
|
Product Classification |
Tube, tracheostomy (w/wo connector) - Product Code BTO
|
Product |
Tracoe Mini 3.0mm Tube, for pediatric use.
Pediatric tracheostomy tube used to provide safe airway access. |
Code Information |
The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752 |
Recalling Firm/ Manufacturer |
Bryan Medical Inc 6811 Mount Vernon Ave Cincinnati OH 45227
|
For Additional Information Contact |
Andrew J. Georgilis 513-272-1600
|
Manufacturer Reason for Recall |
The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
|
FDA Determined Cause 2 |
Labeling Change Control |
Action |
The consignees were contacted by telephone and asked to return the recalled product. |
Quantity in Commerce |
5 units |
Distribution |
Distributed in KY and AL. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = BTO and Original Applicant = HOOD LABORATORIES
|