Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
FDA Recall Z-0301-06 · Posted 2005-12-23
Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeBTO
Date Initiated2005-07-25
Date Terminated2007-12-04
Product Quantity91
Reason for Recall
Instructions for use included in the package are for a different tracheostomy tube.
Firm Action
Consignees were notified via 'precautionary product advisory notification' letter dated July 25, 2005.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.