Smiths Medical ASD, Inc. Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Lot G667991.
Products Sold
Lot G667991.
Smiths Medical ASD, Inc. is recalling Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70. due to Instructions for use included in the package are for a different tracheostomy tube.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Instructions for use included in the package are for a different tracheostomy tube.
Recommended Action
Per FDA guidance
Consignees were notified via 'precautionary product advisory notification' letter dated July 25, 2005.
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 noticePage updated: Jan 10, 2026