Smiths Medical ASD, Inc. Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Lot 1338010.
Products Sold
Lot 1338010.
Smiths Medical ASD, Inc. is recalling Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040. due to The word PED was printed on the neckflange instead of the word NEO.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The word PED was printed on the neckflange instead of the word NEO.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, IL, IN, MD, TN, TX, VA
Page updated: Jan 10, 2026