Recall Class: Class I
Date Recall Initiated: April 17, 2013
Product: Tracoe Mini 3.0mm Tracheostomy Tube
- Model: 350-3.0
- Lot Number: 000-1000071752
The affected products were manufactured from December 12, 2012, to January 14, 2013, and distributed from April 9, 2013, to April 12, 2013.
Use: The Tracoe Mini 3.0mm Tracheostomy Tube is intended to be placed into a surgical opening of the trachea (windpipe) to provide safe airway access and to remove discharge from the lungs. These devices are indicated for use in neonatal and pediatric patients.
Bryan Medical, Inc.
6811 Mount Vernon Ave.
Cincinnati, Ohio 45227
Tracoe Medical Gmbh
Reichelsheimer Str. 1
Nieder-Olm, Germany 55268
Reason for Recall:
The Tracoe Mini 3.0mm Tracheostomy Tubes were mislabeled on the device packaging.
The outside of the device packaging stated a 3.0mm neonatal tube. The product inside the box was actually a 3.0mm pediatric tube. Although the neonatal and pediatric tubes have the same inner diameter, the pediatric tube is 4.0mm longer for this particular model.
An oversized tracheostomy tube may cause permanent injury to the trachea. This product may cause serious adverse health consequences, including death.
Public Contact: For questions about this recall, contact Bryan Medical, Inc. at 513-272-1600 Monday through Friday, 7 AM through 6 PM Eastern Standard Time.
FDA District: Cincinnati District Office
On April 17, 2013, the firm notified its customers of the problem by telephone and asked them to return affected devices for replacement.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.