Z-1667-2013 Class I Terminated
FDA device recall Z-1667-2013 was initiated by Bryan Medical Inc on April 17, 2013 and is designated Class I. Reason for recall: The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. The recall status is terminated (terminated October 29, 2013). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 17, 2013
- Initiation Date
- April 17, 2013
- Termination Date
- October 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
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.
Distribution Pattern
Distributed in KY and AL.
Code Information
The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752