Smiths Medical ASD, Inc. Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 130 mm; REF 67HA80. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 130 mm; REF 67HA80.
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
G711880.
Products Sold
G711880.
Smiths Medical ASD, Inc. is recalling Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length due to Sterility is compromised by incomplete package seal.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility is compromised by incomplete package seal.
Recommended Action
Per FDA guidance
Certified letters were sent to each consignee on 12/ 16/05 and distributors were requested to notify their customers of the recall.
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