Smiths Medical ASD, Inc. Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Lot G653628.
Products Sold
Lot G653628.
Smiths Medical ASD, Inc. is recalling Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product due to The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.
Recommended Action
Per FDA guidance
Consignee was notified via recall letter dated April 19, 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 noticeDistribution
As reported by FDA
CA, IN, NC
Page updated: Jan 10, 2026