Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
This recall has been terminated (originally issued December 23, 2005).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- February 17, 2005
- Posted
- December 23, 2005
- Terminated
- December 4, 2007
- Recall Number
- Z-0302-06
- Quantity
- 26
- Firm Location
- Gary, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The word PED was printed on the neckflange instead of the word NEO.
Distribution
Georgia, Illinois, Indiana, Maryland, Tennessee, Texas and Virginia.
Lot / Code Info
Lot 1338010.
Root Cause
Other
Action Taken
Consignees were notified via 'product advisory letter' dated 2/17/05 and requested to either notify all users or to return the product for replacement.
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