Bivona Tracheostomy Tube Tracheostomy Tubes
FDA Recall Z-2114-2018 · Posted None
Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeBTO
Date Initiated2018-04-02
Date Terminated2018-11-14
Product Quantity16 units
Reason for Recall
Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
Firm Action
Customers were notified via letter on approximately 04/02/2018. Instructions included to determine if there are any affected Customized Bivona Tracheostomy Tubes in inventory, notify customers if the devices have been further distributed, arrange for the return of affected devices, and complete and return the acknowledgement response form.
Root Cause
Error in labeling
Distribution Pattern
Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.