Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
This recall has been terminated (originally issued June 25, 2005).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- April 26, 2005
- Posted
- June 25, 2005
- Terminated
- October 26, 2005
- Recall Number
- Z-0930-05
- Quantity
- 48
- Firm Location
- Gary, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
Distribution
Connecticut, Georgia, Illinois, Indiana, Minnesota, Missouri, New Mexico, and North Carolina.
Lot / Code Info
Lot G651610.
Root Cause
Other
Action Taken
Consignees were notified via letter dated 4/26/05.
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