Smiths Medical ASD, Inc. Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Lot 490694
Products Sold
Lot 490694
Smiths Medical ASD, Inc. is recalling Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080 due to Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm
Recommended Action
Per FDA guidance
Smiths Medical ASD, Inc. notified US customers by letter dated 3/7/06. Accounts are requested to return inventory.
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