Z-0930-05
Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code...
Abbott Medical / initiated 2005-04-26 / Terminated / root cause: labeling and UDI
Smiths Medical ASD, Inc. began a recall of Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035 on . The reason FDA records is "The obturator may be 3.0 mm in length instead of the labeled 3.5 mm". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0930-05
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Abbott Medical
- Product
- Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
- Product code
- JOH Tube Tracheostomy And Tube Cuff
- Reason for recall
- The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
- Root cause tag
- labeling and UDI
- FDA root cause
- Other
- Action
- Consignees were notified via letter dated 4/26/05.
- Quantity in commerce
- 48
- Distribution
- Connecticut, Georgia, Illinois, Indiana, Minnesota, Missouri, New Mexico, and North Carolina.
- Product codes and lots
- Lot G651610.
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