Devices

Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.

Model / Serial
Lot G651610.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Connecticut, Georgia, Illinois, Indiana, Minnesota, Missouri, New Mexico, and North Carolina.
Product Description
Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
Manufacturer
Smiths Medical ASD, Inc.
1 Event
- Recall of Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.

Manufacturer

Smiths Medical ASD, Inc.

Manufacturer Address
Smiths Medical ASD, Inc., 5700 W 23rd Ave, Gary IN 46406-2617
Manufacturer Parent Company (2017)
Smiths Group Plc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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